Orca1

Data catalog

PMA approvals

About 1,529 records

All records

Every PMA record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

  1. BP000009Calypte HIV-1 Urine EIA
  2. BP000023MedMira Rapid HIV Test
  3. BP003600Dermagraft
  4. BP010009Cambridge Biotech HIV-1 Urine Western Blot
  5. BP010047OraQuick ADVANCE Rapid HIV-1/2 Antibody Test
  6. BP011600Orcel
  7. BP030025Uni-Gold Recombigen HIV-1
  8. BP040046Multispot HIV-1/HIV-2 Rapid Test
  9. BP050009Chembio HIV Reactive/Nonreactive Controls; SURE CHECK HIV 1/2 ASSAY
  10. BP050010Chembio HIV Reactive/Nonreactive Controls; HIV 1/2 STAT-PAK ASSAY
  11. BP050030ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents
  12. BP050051VITROS Immunodiagnostics Products Anti-HIV 1+2 Calibrator; VITROS Immunodiagnostics…
  13. BP050069COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, 48 Tests; COBAS AmpliPrep/COBAS TaqMan Wash…
  14. BP060001CryoSeal FS System
  15. BP060002Abbott RealTime HIV-1 Amplification Reagent Kit; Abbott RealTime HIV-1 Calibrator Kit…
  16. BP090022Avioq HIV-1 Microelisa System
  17. BP090032INSTI¿ HIV-1 Antibody Test Kit
  18. BP090080ARCHITECT HIV Ag/Ab Combo Assay
  19. BP100064GS HIV Combo Ag/Ab EIA
  20. BP120001OraQuick® In-Home HIV Test
  21. BP120032DPP HIV 1/2 Assay
  22. BP120037Alere DetermineTM HIV-1/2 Ag/Ab Combo
  23. BP130026Immucor PreciseType™ Human Erythrocyte Antigen Molecular BeadChip Test
  24. BP130076INTERCEPT(R) Blood System for Plasma
  25. BP140103ADVIA Centaur HIV Ag/Ab Combo (CHIV) Assay
  26. BP140111BioPlex? 2200 HIV Ag-Ab
  27. BP140120Bio-Rad Geenius HIV 1/2 Supplemental Assay
  28. BP140143INTERCEPT(R) Blood Systerm for Platelets
  29. BP150262cobas HIV-1
  30. BP150318Aptima HIV-1 Quant Dx assay
  31. BP160050Elecsys HIV combi PT
  32. BP160122VITROS Immunodiagnostic Products HIV Combo Calibrator; VITROS Immunodiagnostic Products…
  33. BP170122ReCell Autologous Cell Harvesting Device
  34. BP170154ID CORE XT
  35. BP180191DPP? HIV-Syphilis System
  36. BP180279VioOne HIV Profile Supplemental Assay
  37. BP190360cobas? HIV-1/HIV-2 Qualitative
  38. BP190403Elecsys HIV Duo
  39. BP190437LIAISON? XL MUREX Control HIV Ab/Ag HT
  40. BP200455Alinity m HIV-1
  41. BP220799RECELL Autologous Cell Harvesting Device
  42. BP850001Autopheresis-C Plasmapheresis System
  43. BP910001Orasure HIV-1 Oral Specimen Collection Device
  44. BP950002Home Access HIV-1 Test System
  45. BP950004OraSure HIV-1 Western Blot Kit
  46. BP953200Apligraf
  47. BP960700Dermagraft-TC (temporary covering)
  48. N12159SURGICEL BRAND ABSORBABLE HEMOSTAT
  49. N13787ENUCLENE CLEANING/LUBRICATING SOLUTION
  50. N16420MENTOR POLYTEF PASTE FOR INJECTION
  51. N16837ARTEGRAFT{TM} AND REINFORCED ARTEGRAFT{TM}
  52. N16895SOFLENS CONTACT LENSES (POLYMACON)
  53. N17003SURGICAL SIMPLED P BONE CEMENT
  54. N17004SURGICAL SIMPLEX P RADEOPAQUE BONE CEMENT
  55. N17113OMNIPLASTIC BONE CEMENT
  56. N17397ACEPTOPLAST CONTACT LENS
  57. N17433PRE OP SPONGE
  58. N17511HYSKON (32% DEXTRAN 70)
  59. N17578INDIRECT FLUORESCENT-ANTIBODY TEST FOR GONORRHEA (IFA-GC)
  60. N17600AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT)
  61. N17622FLOURESCEIN SODIUM OPHTHALMIC STRIPS
  62. N17679TETRAFILCON A
  63. N17752HYDROCURVE
  64. N17755ZIMMER(R) BONE CEMENT
  65. N17796BRYREL SYRUP
  66. N17945ADAPETTES
  67. N17987CSI CONTACT LENS
  68. N18033ACUVUE CONTACT LENS
  69. N18143PREFLEX AND FLEXCARE SOL.
  70. N18286GELFOAM
  71. N18466CMW BONE CEMENT
  72. N50009TERRAMYCIN DIAGNOSTIC SUSCEPTIBILITY POWDER
  73. N50016BACITRACIN DIAGNOSTIC SUSCEPTIBILITY POWDER
  74. N50036STREPTOMYCIN SUEFATE DIAGNOSTIC SUSCEPTIBILITY POW
  75. N50042POTASSIUM PENICILLIN G DIAG SYS POWDER
  76. N50061POLYMYXIN B SULFATE SUSCEPTIBILITY TESTING
  77. N50062OLEANDOMYCIN PHOSPHATE SUSCEPTIBILITY POWDER
  78. N50100VIBRAMYCIN DIAG. SUSCEPTIBILITY POWDER (DOXYCYCLIN
  79. N50163STERILE CLEOCIN SUSCEPTIBILITY PWD (CLINDAMYCIN)
  80. N50407STERILE TROBICIN SUSCEPTIBILITY POWDER(STERILE SPE
  81. N50413GEOPEN SUSCEPTIBILITY POWDER
  82. N50487MIC TEST PANELS
  83. N50494MIC ANTIBIOTIC TEST PANELS
  84. N50510VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD
  85. N50524AUTOBAC MIC TEST SYSTEM
  86. N50525ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM
  87. N50531SENSITITRE
  88. N50538FLOW MIC SYSTEM
  89. N60242MS 2 AUTOMATED SYSTEM
  90. N61034LINCOCIN SUSCEPTIBILITY PWD
  91. N62160MIC PANELS
  92. N80023ABSORBABLE DUSTING POWDER
  93. N80535ABSORBO(R) DUSTING POWDER
  94. N85356ABSORBABLE DUSTING POWDER
  95. N970003PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE
  96. N970012AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES
  97. N980003KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
  98. P000005CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM
  99. P000006TITAN INFLATABLE PENILE PROSTHESIS
  100. P000007EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P
  101. P000008LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
  102. P000009PHYLAX AV ICD SYSTEM
  103. P000010AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0
  104. P000011BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM
  105. P000012COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0
  106. P000013TRIDENT SYSTEM
  107. P000014VITROS IMMUNODIAGNOSTIC PRODUCTS:ANTI-HBS REAGENT PACK/ANTI-HBS CALIBRATORS
  108. P000015NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
  109. P000016COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR
  110. P000018BETA-CATH (TM) SYSTEM
  111. P000020STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE
  112. P000021DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE
  113. P000022BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
  114. P000023TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES
  115. P000025COMBI 40+ COCHLEAR IMPLANT SYSTEM
  116. P000026STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20
  117. P000027ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK
  118. P000028AFFINITY (TM) CAGE SYSTEM
  119. P000029DEFLUX INJECTABLE GEL
  120. P000030FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES
  121. P000032HER OPTION (TM) UTERINE CRYOBLATION THERAPY SYSTEM
  122. P000033INTRA COIL SELF-EXPANDING PERIPHERAL STENT
  123. P000035TMJ FOSSA-EMINENCE PROSTHESIS(TM)
  124. P000036DERMAGRAFT
  125. P000037ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA
  126. P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM
  127. P000040HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM
  128. P000041RAPIDSCREEN RS-2000
  129. P000043TMX-2000 BPH THERMOTHERAPY SYSTEM
  130. P000044VITROS IMMUNODIAGNOSTIC PRODUCTS/HBSAG REAGENT PACK,VITROS IMMUNODIAGNOSTIC PRODUCTS…
  131. P000046STAARVISC II
  132. P000048DORNIER EPOS ULTRA
  133. P000049CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD
  134. P000052GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
  135. P000053AMS SPHINCTER 800 URINARY CONTROL SYSTEM
  136. P000054INFUSE BONE GRAFT
  137. P000055UBIS 5000 BONE SONOMETER
  138. P000057ASCENSION MCP
  139. P000058INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
  140. P010001CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
  141. P010002INDERMIL(TM) TISSUE ADHESIVE
  142. P010003BIOGLUE SURGICAL ADHESIVE
  143. P010007IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP
  144. P010012CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC…
  145. P010013NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
  146. P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM
  147. P010015MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM
  148. P010016ORCEL BILAYERED CELLULAR MATRIX
  149. P010017SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
  150. P010018VIEWPOINT(TM) CK SYSTEM
  151. P010019FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
  152. P010020AMS ACTICON NEOSPHINCTER
  153. P010021VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
  154. P010022COSEAL SURGICAL SEALANT (COSEAL)
  155. P010023SOUNDTEC DIRECT SYSTEM
  156. P010025LORAD DIGITAL BREAST IMAGER
  157. P010027ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)
  158. P010029EUFLEXXA (1% SODIUM HYALURONATE)
  159. P010030WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST
  160. P010031CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH…
  161. P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS
  162. P010033QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBE
  163. P010034SECOND LOOK (TM)
  164. P010038SECOND LOOK
  165. P010039SIEMENS SONOCUR BASIC SYSTEM
  166. P010040THE DISINTEGRATOR INSULIN NEEDLE DESTRUCTION DEVICE
  167. P010041CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)
  168. P010043LEA'S SHIELD BARRIER CONTRACEPTIVE
  169. P010047PROGEL PLEURAL AIR LEAK SEALANT
  170. P010049QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM
  171. P010050IMMULITE 2000 XPI HBSAG
  172. P010051IMMULITE 2000 XPI ANTI-HBC
  173. P010052IMMULITE 2000 XPI ANTI-HBS
  174. P010053IMMULITE 2000 XPI ANTI-HBC IMG
  175. P010054ELECSYS ANTI-HBS
  176. P010055PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
  177. P010058OSTEOSPACE
  178. P010059MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C
  179. P010061CURELIGHT BROADBAND (MODEL CURELIGHT 01)
  180. P010062EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR
  181. P010065NEEDLE ZAP (R)
  182. P010068NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER
  183. P020001STAN S31 FETAL HEART MONITOR
  184. P020002THINPREP (R) IMAGING SYSTEM
  185. P020003COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS
  186. P020004EXCLUDER BIFURCATED ENDOPROSTHESIS
  187. P020006ENTERYX PROCEDURE KIT
  188. P020007MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYSTEM
  189. P020008KARL STORZ AUTOFLUORESCENCE SYSTEM
  190. P020009EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS
  191. P020011VERSANT HCV RNA QUALITATIVE ASSAY
  192. P020012ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER
  193. P020014ESSURE SYSTEM
  194. P020016WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
  195. P020018ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM
  196. P020021WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER
  197. P020022BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)
  198. P020023RESTYLANE INJECTABLE GEL
  199. P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
  200. P020025EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM
  201. P020026CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR…
  202. P020027DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL…
  203. P020028SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN…
  204. P020030STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD
  205. P020031MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM
  206. P020033INDEPENDENCE (TM) IBOT 3000/4000 MOBILITY SYSTEM
  207. P020035X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM
  208. P020036S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
  209. P020037FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
  210. P020040NIRFLEX PREMOUNTED STENT
  211. P020041FEMCAP BARRIER CONTRACEPTIVE
  212. P0200457F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM
  213. P020047MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMS
  214. P020049PROCOL VASCULAR BIOPROSTHESIS
  215. P020050WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
  216. P020052RESPONSE CV CATHETER SYSTEM
  217. P020055VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY
  218. P020056NATRELLE SILICONE-FILLED BREAST IMPLANTS
  219. P030002CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
  220. P030004ONYX LIQUID EMBOLIC SYSTEM
  221. P030005CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
  222. P030006PROLIEVE THERMODILATATION SYSTEM
  223. P030007KODAK MAMMOGRAPHY CAD ENGINE
  224. P030008WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
  225. P030009DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS
  226. P030010SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
  227. P030011SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)
  228. P030012IMAGECHECKER CT CAD SOFTWARE SYSTEM
  229. P030016VISIAN ICL (IMPLANTABLE COLLAMER LENS)
  230. P030017PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM
  231. P030019ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN
  232. P030022REFLECTION CERAMIC ACETABULAR SYSTEM
  233. P030023OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
  234. P030024VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK/CALIBRATOR
  235. P030025TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
  236. P030026VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR
  237. P030027CERAMIC TRANSCEND HIP ARTICULATION
  238. P030028ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US)…
  239. P030029ADVIA CENTAUR ANTI-HBS READYPACK REAGENTS AND CALIBRATORS
  240. P030030URYX URETHRAL BULKING AGENT
  241. P030031BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP…
  242. P030032HYLAFORM (HYLAN B GEL)
  243. P030034CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM
  244. P030035ANTHEM AND FRONTIER II CRT-P'S
  245. P030036MEDTRONIC SELECTSECURE LEAD MODEL 3830
  246. P030037RITHRON-XR CORONARY STENT SYSTEM
  247. P030039COSEAL SURGICAL SEALANT
  248. P030040ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
  249. P030042CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM
  250. P030044DAKOCYTOMATION EGFR PHARMDX
  251. P030045INTRASTENT DOUBLESTRUT STENT
  252. P030047CORDIS PRECISE NITINOL STENT SYSTEM
  253. P030049ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL…
  254. P030050SCULPTRA AND SCULPTRA AESTHETIC
  255. P030052UROVYSION BLADDER CANCER KIT
  256. P030053MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS
  257. P030054ST JUDE MEDICAL EPIC HF SYSTEM
  258. P030056ADVIA CENTAUR HCV READY PACK REAGENTS, ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS
  259. P040001X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
  260. P040002ENDOLOGIX POWERLINK SYSTEM
  261. P040003EXABLATE 2000 SYSTEM
  262. P040004ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL…
  263. P040005DAKOCYTOMATION HER2 FISH PHARMDX KIT
  264. P040006CHARITE ARTIFICIAL DISC
  265. P040008VIDAS TPSA ASSAY
  266. P040011C-KIT PHARMDX
  267. P040012ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
  268. P040013GEM 21S (GROWTH-FACTOR ENHANCED MATRIX
  269. P040014IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR
  270. P040016VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM
  271. P040017ADVIA CENTAUR HAV TOTAL ASSAY, ADVIA CENTAUR HAV TOTAL QUALITY CONTROL MATERIALS
  272. P040018ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS
  273. P040020ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL
  274. P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
  275. P040022ANGIOLINK VASCULAR CLOSURE SYSTEM
  276. P040023DURALOC OPTION CERAMIC HIP SYSTEM
  277. P040024RESTYLANE INJECTABLE GEL
  278. P040025OLYMPIC COOL-CAP
  279. P040026ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE
  280. P040027GORE VIATORR TIPS
  281. P040028LUMA CERVICAL IMAGING SYSTEM
  282. P040029Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid…
  283. P040030INSITE HER-2/NEU KIT
  284. P040033BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
  285. P040034DURASEAL DURAL SEALANT SYSTEM
  286. P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
  287. P040037VIABAHN ENDOPROSTHESIS
  288. P040038XACT CAROTID STENT SYSTEM
  289. P040039ORBASONE PAIN RELIEF SYSTEM
  290. P040040AMPLATZER MUSCULAR VSD OCCLUDER
  291. P040042THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX…
  292. P040043GORE TAG THORACIC ENDOPROSTHESIS
  293. P040044MATRIX VASCULAR CLOSURE SYSTEM (VSG)
  294. P040045VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
  295. P040046NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
  296. P040047COAPTITE
  297. P040048TRILOGY AB ACETABULAR SYSTEM
  298. P040050MACROPLASTIQUE IMPLANTS
  299. P040051STELKAST SURPASS ACETABULAR SYSTEM
  300. P040052MONOPREP PAP TEST
  301. P050004EMS SWISS DOLORCLAST
  302. P050006GORE HELEX SEPTAL OCCLUDER
  303. P050007STARCLOSE VASCULAR CLOSURE SYSTEM
  304. P050009C2 A-TAPER ACETABULAR SYSTEM
  305. P050010PRODISC -L TOTAL DISC REPLACEMENT DEVICE
  306. P050011ADEPT (4% ICODEXTRIN) ADHESION REDUCTION SOLUTION
  307. P050012DEXCOM STS CONTINOUS MONITORS
  308. P050013HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
  309. P050014FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS)
  310. P050016CORMET HIP RESURFACING SYSTEM
  311. P050017ZILVER VASCULAR STENT
  312. P050018ANGIOSCULPT SCORING BALLOON CATHETER
  313. P050019CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
  314. P050020FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR
  315. P050021CERALAS I LASER
  316. P050022SYNGO LUNG CAD
  317. P050023TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD
  318. P050024CRYOCOR CRYOABLATION SYSTEM
  319. P050025ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL…
  320. P050026QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS
  321. P050027KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM
  322. P050028COBAS TAQMAN HBV TEST
  323. P050029HELIOS II ABLATION CATHETER
  324. P050031PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL…
  325. P050033HYDRELLE
  326. P050034IMPLANTABLE MINIATURE TELESCOPE (IMT)
  327. P050037RADIESSE 1.3CC AND 0.3CC
  328. P050038ARISTA AH ABSORBABLE HEMOSTAT
  329. P050039NOVATION CERAMIC ARTICULATION HIP SYSTEM
  330. P050040SPOT-LIGHT HER2 CISH KIT
  331. P050042ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
  332. P050043FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH
  333. P050044VITAGEL RT3 SUTGICAL HEMOSTAT
  334. P050045DAKO TOP2A FISH PHARMDX KIT
  335. P050046ACUITY STEERABLE LEAD SYSTEM
  336. P050047JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS
  337. P050048MONOLISA ANTI-HBS EIA
  338. P050049AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS
  339. P050050SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
  340. P050051ABBOTT ARCHITECT AUSAB
  341. P050052RADIESSE INJECTABLE IMPLANT
  342. P050053INFUSE BONE GRAFT
  343. P060001PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS
  344. P060002FLAIR ENDOVASCULAR STENT GRAFT
  345. P060003AXSYM, AUSAB
  346. P060004MEL 80 EXCIMER LASER SYSTEM
  347. P060005IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS
  348. P060006BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM
  349. P060007ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY…
  350. P060008TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
  351. P060009AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS
  352. P060010THE SPANNER TEMPORARY PROSTATIC STENT
  353. P060011C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
  354. P060012AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS
  355. P060017GENESEARCH BREAST LYMPH NODE(BLN) ASSAY
  356. P060018PRESTIGE CERVICAL DISC SYSTEM
  357. P060019IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF
  358. P060022AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT
  359. P060023BRYAN CERVICAL DISC PROSTHESIS
  360. P060025ATS 3F AORTIC BIOPROSTHESIS
  361. P060027OVATIO CRT SYSTEM
  362. P060028MENTOR MEMORYSHAPE BREAST IMPLANTS
  363. P060029ETHICON OMNEX SURGICAL SEALANT
  364. P060030COBAS AMPLIPREP/COBAS TAQMAN HCV TEST
  365. P060031BIO-RAD MONOLISA ANTI-HBC EIA
  366. P060033ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM
  367. P060034BIO RAD MONOLISA ANTI-HBC IGM EIA
  368. P060035ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS
  369. P060037NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM
  370. P060038MITROFLOW AORTIC PERICARDIAL HEART VALVE
  371. P060039ATTAIN STARFIX MODEL 4195 LEAD
  372. P060040THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
  373. P070001PRODISC TM-C TOTAL DISC REPLACEMENT
  374. P070004SIENTRA SILICONE GEL BREAST IMPLANTS
  375. P070005REPEL-CV BIORESORBABLE ADHESION BARRIER
  376. P070006T SPOT-TB TEST
  377. P070007TALENT THORACIC STENT GRAFT SYSTEM
  378. P070008STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD
  379. P070009REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X
  380. P070012EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY…
  381. P070013EVOLENCE COLLAGEN FILLER
  382. P070014LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM
  383. P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
  384. P070016ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
  385. P070022ADIANA PERMANENT CONTRACEPTION SYSTEM
  386. P070026CERAMAX CERAMIC HIP SYSTEM
  387. P070027THE TALENT ABDOMINAL STENT GRAFT SYSTEM
  388. P080002FC2 FEMALE CONDOM
  389. P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
  390. P080004HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
  391. P080006MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD
  392. P080007BARD E-LUMINEXX VASCULAR STENT
  393. P080008VIDAS FREE PSA RT ASSAY
  394. P080009SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
  395. P080010TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
  396. P080011BIOFINITY (COMFILCON A)
  397. P080012PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
  398. P080013DURASEAL EXACT SPINE SEALANT SYSTEM
  399. P080014CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT
  400. P080015CERVISTA HPV 16/18
  401. P080018KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY
  402. P080020GEL-ONE
  403. P080021XACT FOLDABLE HYDROPHOBIC ACRYLIC ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER…
  404. P080023ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
  405. P080025MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
  406. P080026ABBOTT REALTIME HBV ASSAY
  407. P080027ORAQUICK HCV RAPID ANTIBODY TEST
  408. P080028STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY
  409. P080029QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)
  410. P080030GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
  411. P080032ALAIR BRONCHIAL THERMOPLASTY SYSTEM
  412. P090002PINNACLE COMPLETE ACETABULAR HIP SYSTEM
  413. P090003EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM
  414. P090006COMPLETE SE VASCULAR STENT SYSTEM
  415. P090007ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411…
  416. P090008ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601…
  417. P090009ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS…
  418. P090012MELAFIND
  419. P090013REVO MRI SURESCAN IPG AND PACING SYSTEM
  420. P090015BOND ORACLE HER2 IHC SYSTEM
  421. P090016BELOTERO BALANCE
  422. P090018ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM
  423. P090022LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
  424. P090024ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL
  425. P090026ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS
  426. P090028VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE…
  427. P090029PRESTIGE LP CERVICAL DISC
  428. P090031MONOVISC
  429. P100001VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE…
  430. P100003SECURE-C ARTIFICIAL CERVICAL DISC
  431. P100005M-VU ALGORITHM ENGINE
  432. P100006AUGMENT BONE GRAFT
  433. P100007BREAST COMPANION SOFTWARE SYSTEM
  434. P100009MITRACLIP DELIVERY SYSTEM
  435. P100010ARCTIC FRONT CRYOCATHETER SYSTEM
  436. P100012NUVASIVE PCM CERVICAL DISC SYSTEM
  437. P100013CORDIS EXOSEAL VASCULAR CLOSURE DEVICE
  438. P100014SOLESTA INJECTABLE GEL
  439. P100016EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL
  440. P100017ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC…
  441. P100018PIPELINE EMBOLIZATION DEVICE
  442. P100020COBAS HPV TEST
  443. P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM
  444. P100022ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
  445. P100023ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS)
  446. P100024HER2 CISH PHARMDX KIT
  447. P100025BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION…
  448. P100026NEUROPACE RNS SYSTEM
  449. P100027INFORM HER2 DUAL ISH DNA PROBE COCKTAIL
  450. P100028FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
  451. P100029ST JUDE MEDICAL TRIFECTA VALVE
  452. P100030ARTERX SURGICAL SEALANT
  453. P100031ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC
  454. P100032ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010…
  455. P100033PROGENSA PCA3 ASSAY
  456. P100034NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT
  457. P100039ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL
  458. P100040VALIANT THORACIC STENT GRAFT SYSTEM
  459. P100041EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  460. P100042APTIMA HPV ASSAY
  461. P100044PROPEL
  462. P100045CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM
  463. P100046ATRICURE SYNERGY ABLATION SYSTEM
  464. P100047HEARTWARE VENTRICULAR ASSIST SYSTEM
  465. P100049LINX REFLUX MANAGEMENT SYSTEM
  466. P110001RX HERCULINK ELITE RENAL STENT SYSTEM
  467. P110002MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)
  468. P110003LEGOO
  469. P110004PRESILLION PLUS COCR CORONARY STENT RX SYSTEM
  470. P110005SINOVIAL (SODIUM HYALURONATE 0.8%)
  471. P110006SOMO.V ABUS (AUTOMATED BREAST ULTRASOUND SYSTEM)
  472. P110007HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE)
  473. P110008COFLEX® INTERLAMINAR TECHNOLOGY
  474. P110009MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
  475. P110010PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
  476. P110011ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
  477. P110012VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION…
  478. P110013RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
  479. P110014DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
  480. P110015GASTRIC EMPTYING BREATH TEST (GEBT)
  481. P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC…
  482. P110019Xience Skypoint Everolimus Eluting Coronary Stent System
  483. P110020COBAS 4800 BRAF V600 MUTATION TEST
  484. P110021EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
  485. P110022ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
  486. P110023EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)
  487. P110024RESQCPR SYSTEM
  488. P110025ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR…
  489. P110027THERASCREEN KRAS RGQ PCR KIT
  490. P110028ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
  491. P110029ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT…
  492. P110030THERASCREEN KRAS RGQ PCR KIT
  493. P110031ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
  494. P110032AORFIX FLEXIBLE STENT GRAFT SYSTEM
  495. P110033JUVEDERM VOLUMA XC
  496. P110035EPIC SELF-EXPANDING NITINOL STENT SYSTEM
  497. P110037COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
  498. P110038RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
  499. P110039EXABLATE
  500. P110040MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM
  501. P110041ADVIA CENTAUR HBSAGII
  502. P110042SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
  503. P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM
  504. P120002SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS
  505. P120003iCast Covered Stent System
  506. P120004PARASCRIPT ACCUDETECT 6.1.0
  507. P120005DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
  508. P120006OVATION ABDOMINAL STENT GRAFT SYSTEM
  509. P120007APTIMA HPV 16 18/45 GENOTYPE ASSAY
  510. P120008ABBOTT ARCHITECT AFP ASSAY
  511. P120009NIT-OCCLUD PDA
  512. P120010MINIMED 530G SYSTEM
  513. P120011Puregraft Serene Breast Implant
  514. P120012ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT…
  515. P120014BIOMERIEUX THXID BRAF ASSAY KIT
  516. P120016VASCADE VASCULAR CLOSURE SYSTEM
  517. P120017MODEL 5071 LEAD
  518. P120018SHARPS TERMINATOR
  519. P120019COBAS EGFR MUTATION TEST
  520. P120020SUPERA PERIPHERAL STENT SYSTEM
  521. P120021AMPLATZER PFO OCCLUDER
  522. P120022THERASCREEN EGFR RGQ PCR KIT
  523. P120023KAMRA INLAY
  524. P120024ACTIVL ARTIFICIAL DISC
  525. P130001Epi proColon
  526. P130004RESURE SEALANT
  527. P130005DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
  528. P130006GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
  529. P130007ANIMAS VIBE SYSTEM
  530. P130008INSPIRE II UPPER AIRWAY STIMULATOR
  531. P130009EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
  532. P130010VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)
  533. P130011FREEDOM SOLO STENTLESS HEART VALVE
  534. P130012MYOPORE SUTURELESS MYOCARDIAL PACING LEAD
  535. P130013WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY
  536. P130014ADHERUS AUTOSPRAY DURAL SEALANT
  537. P130015ELECSYS® HBEAG IMMUNOASSAY AND ELECSYS® PRECICONTROL HBEAG
  538. P130016NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM
  539. P130017COLOGUARD
  540. P130018PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN
  541. P130019MAESTRO RECHARGEABLE SYSTEM
  542. P130020SENOCLAIRE
  543. P130021MEDTRONIC COREVALVE SYSTEM
  544. P130022NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM
  545. P130023COHERA MEDICAL TISSUGLU
  546. P130024LUTONIX DRUG COATED BALLOON PTA CATETER
  547. P130025KONING BREAST CT (MODEL CBCT1000)
  548. P130026TACTICATH QUARTZ SET
  549. P130027ARTUS CMV RGQ MDX KIT
  550. P130028ALGOVITA SPINAL CORD STIMULATION SYSTEM
  551. P130029FLUENCY PLUS ENDOVASCULAR STENT GRAFT
  552. P130030REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE
  553. P140002MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
  554. P140003IMPELLA 2.5 System
  555. P140004SUPERION INTERSPINOUS SPACER
  556. P140005GENVISC 850
  557. P140008ORBERA INTRAGASTRIC BALLOON
  558. P140009BRIO NEUROSTIMULATION SYSTEM
  559. P140010IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon…
  560. P140011MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
  561. P140012RESHAPE INTEGRATED DUAL BALLOON SYSTEM
  562. P140013MINERVA ENDOMETRIAL ABLATION SYSTEM
  563. P140015T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM
  564. P140016ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
  565. P140017MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM…
  566. P140018VENASEAL CLOSURE SYSTEM
  567. P140019I-FACTOR PEPTIDE ENHANCED BONE GRAFT
  568. P140020BRACANALYSIS CDX
  569. P140021ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
  570. P140023COBAS KRAS MUTATION TEST
  571. P140025VENTANA ALK (D5F3) CDX ASSAY
  572. P140026ENROUTE TRANSCAROTID STENT SYSTEM
  573. P140028INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
  574. P140029Restylane Refyne, Restylane Defyne
  575. P140030ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM
  576. P140031SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES
  577. P140032Implantable System for Remodulin
  578. P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS…
  579. P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)
  580. P150002INCRAFT(R) AAA STENT GRAFT SYSTEM
  581. P150003SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
  582. P150004Axium Neurostimulator System
  583. P150005BLAZER OPEN-IRRIGATED ABLATION CATHETER
  584. P150006CELT ACD VASCULAR CLOSURE DEVICE
  585. P150009Guardian System
  586. P150010HYMOVIS
  587. P150011PERCEVAL SUTURELESS HEART VALVE
  588. P150012IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
  589. P150013PD-L1 IHC 22C3 PHARMDX
  590. P150014COBAS HBV TEST
  591. P150015COBAS HCV TEST
  592. P150016TRIDYNE VASCULAR SEALANT
  593. P150017CARTIVA SYNTHETIC CARTILAGE IMPLANT
  594. P150019PARADIGM REAL-TIME REVEL SYSTEM
  595. P150021FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM
  596. P150022CLOSER VASCULAR SEALING SYSTEM
  597. P150023ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM
  598. P150024AspireAssist
  599. P150025PD-L1 IHC 28-8 pharmDx
  600. P150026HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM
  601. P150027PD-L1 IHC 28-8 pharmDx
  602. P150028CHEATHAM PLATINUM (CP) STENT SYSTEM (Covered CP Stent, Covered Mounted CP Stent, CP Stent…
  603. P150029IPRO2 CGM SYSTEM WITH ENLITE SENSOR
  604. P150030R3 DELTA CERAMIC HIP SYSTEM
  605. P150031VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM
  606. P150033MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
  607. P150034Raindrop Near Vision Inlay
  608. P150035Aveir VR Leadless System
  609. P150036EDWARDS INTUITY ELITE VALVE SYSTEM
  610. P150037CyPass Micro-Stent
  611. P150038EXABLATE
  612. P150039TRYTON SIDE BRANCH STENT
  613. P150040VISUMAX FEMTOSECOND LASER
  614. P150041VYSIS CLL FISH PROBE KIT
  615. P150042ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM
  616. P150043QVCAD SYSTEM
  617. P150044cobas EGFR MUTATION TEST v2
  618. P150045ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM
  619. P150046NEVISENSE
  620. P150047cobas EGFR MUTATION TEST v2
  621. P150048EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA…
  622. P160001OBALON BALLOON SYSTEM
  623. P160002VENTANA PD-L1(SP142) CDX ASSAY
  624. P160003PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM
  625. P160004GORE TIGRIS VASCULAR STENT
  626. P160006VENTANA PD-L1 (SP142) Assay
  627. P160007Guardian Connect system
  628. P160008HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators…
  629. P160009PowerLook® Tomo Detection Software
  630. P160012LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery…
  631. P160013Organ Care System (OCS™) Lung System
  632. P160014COBRA PzF NanoCoated Coronary Stent System
  633. P160015AED Plus and Fully Automatic AED Plus
  634. P160016VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)
  635. P160017MiniMed 670G System
  636. P160018FoundationFocus CDxBRCA
  637. P160019Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II
  638. P160021GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS
  639. P160022X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz…
  640. P160023APTIMA HCV QUANT DX ASSAY
  641. P160024LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT
  642. P160025ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM
  643. P160026LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/…
  644. P160028Philips HeartStart FR3 Defibrillator
  645. P160029HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model…
  646. P160030Freestyle Libre Flash Glucose Monitoring System
  647. P160031ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION
  648. P160032Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300…
  649. P160033Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3
  650. P160034Powerheart® AED G3 Pro
  651. P160035EXCOR Pediatric Ventricular Assist Device
  652. P160036Hintermann Series H3 Total Ankle Replacement System
  653. P160037BD ONCLARITY HPV ASSAY
  654. P160038Praxis Extended RAS Panel
  655. P160039remede® System
  656. P160040LeukoStrat CDx FLT3 Mutation Assay
  657. P160041COBAS CMV
  658. P160042REVANESSE ULTRA
  659. P160043RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
  660. P160044ABBOTT REALTIME CMV
  661. P160045Oncomine Dx Target Test
  662. P160046VENTANA PD-L1 (SP263) ASSAY
  663. P160047MARA™ Vapor System, MARA™ Vapor Probe Procedure Kit, MARA™ Vapor Generator and MARA™ Vapor…
  664. P160048EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
  665. P160049STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
  666. P160050BARRICAID ANULAR CLOSURE DEVICE (ACD)
  667. P160052PartoSure test
  668. P160053MagtraceTM and Sentimag(R) Magnetic Locatization System
  669. P160054HeartMate 3™ Left Ventricular Assist System
  670. P160055LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)
  671. P160057TRIVISC
  672. P170001VIRTIS SACRAL NEUROMODULATION SYSTEM
  673. P170002RHA 2, RHA 3, RHA 4
  674. P170003LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010
  675. P170005Abbott RealTime IDH2
  676. P170006AVALUS(TM) BIOPROSTHESIS
  677. P170007DUROLANE
  678. P170008EluNIR™ Ridaforolimus Eluting Coronary Stent System
  679. P170011Impella RP System
  680. P170012HEMOBLAST™ Bellows
  681. P170013Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
  682. P170016SYNOJOYNT
  683. P170018LIFEPAK® CR2 Defibrillator
  684. P170019FoundationOne CDx
  685. P170022PyloPlus UBT System
  686. P170023Bulkamid Urethral Bulking System
  687. P170024Surpass Streamline Flow Diverter
  688. P170025Aptima HBV Quant Assay
  689. P170027TherOx Downstream System
  690. P170029CALCIVIS Imaging System
  691. P170030ORSIRO Sirolimus Eluting Coronary Stent System
  692. P170032Woven EndoBridge (WEB) Aneurysm Embolization System
  693. P170034HYDRUS MICROSTENT
  694. P170035Bausch + Lomb Ultra (samfilcon A) Contact Lenses
  695. P170036M6-C Artificial Cervical Disc
  696. P170037Sangia Total PSA Test
  697. P170038CentriMag Circulatory Support System
  698. P170039CustomFlex Artificial Iris
  699. P170041Abbott RealTime IDH1
  700. P170042Covera™ Vascular Covered Stent
  701. P170043iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
  702. P180001Zenith Dissection Endovascular System
  703. P180002Zephyr Endobronchial Valve System
  704. P180003BioMimics 3D Vascular Stent System
  705. P180007Spiration® Valve System
  706. P180008t:slim X2 Insulin Pump with Basal-IQ Technology
  707. P180010Gore Carotid Stent
  708. P180011Eluvia Drug-Eluting Vascular Stent System
  709. P180013VICI VENOUS STENT System
  710. P180014XPS™ with Steen Solution™ Perfusate
  711. P180024TransPyloric Shuttle/TransPyloric Shuttle Delivery Device
  712. P180025MANTA Vascular Closure Device
  713. P180027Flow Re-Direction Endoluminal Device (FRED®) System
  714. P180028HeartStart FRx Defibrillator
  715. P180029LOTUS Edge Valve System
  716. P180031Neuroform Atlas® Stent System
  717. P180032Cerene® Cryotherapy Device
  718. P180034Tack Endovascular System (6F)
  719. P180035MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
  720. P180036OPTIMIZER Smart System
  721. P180037Venovo Venous Stent System
  722. P180038LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc
  723. P180039LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX…
  724. P180040TRILURON
  725. P180043therascreen FGFR RGQ RT-PCR Kit
  726. P180045LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM
  727. P180046Axonics Sacral Neuromodulation System
  728. P180047LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON…
  729. P180048LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
  730. P180049LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe
  731. P180050BAROSTIM NEO® System
  732. P180051Organ Care System (OCS) Heart System
  733. P190001therascreen PIK3CA RGQ PCR Kit
  734. P190002Saluda Medical Evoke SCS System
  735. P190004therascreen PIK3CA RGQ PCR Kit
  736. P190005Elecsys Anti-HBe, PreciControl Anti-HBe
  737. P190006Axonics Sacral Neuromodulation System
  738. P190007Cardinal Health Multifunctional Defibrillation Electrode
  739. P190008IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
  740. P190009OPRA Implant System
  741. P190011LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab
  742. P190012Spatz3 Adjustable Balloon System
  743. P190013AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)
  744. P190014myChoice HRD CDx
  745. P190015TREO® Abdominal Stent-Graft System
  746. P190016Tula® System
  747. P190017LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg…
  748. P190018Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric…
  749. P190019Ranger™ Paclitaxel-Coated PTA Balloon Catheter
  750. P190020BioFreedom Drug Coated Coronary Stent System
  751. P190021ReActiv8 Implantable Neurostimulation System
  752. P1900224Kscore Test
  753. P190023Portico Transcatheter Aortic Valve Implantation System
  754. P190024CINtec PLUS Cytology
  755. P190025Alinity m HCV
  756. P190026therascreen BRAF V600E RGQ PCR Kit
  757. P190027Tack Endovascular System (4F, 1.5-4.5mm)
  758. P190028cobas HPV for use on the cobas 6800/8800 Systems
  759. P190030ActaStim-S Spine Fusion Stimulator
  760. P190031HER2 Dual ISH DNA Probe Cocktail
  761. P190032FoundationOne Liquid CDx (F1 Liquid CDx)
  762. P190033AAV5 DetectCDx
  763. P190034Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
  764. P200002EPi-Sense Guided Coagulation System
  765. P200003Imagio Breast Imaging System
  766. P200004ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters
  767. P200005TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors
  768. P200006FoundationOne Liquid CDx (F1 Liquid CDx)
  769. P200007HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
  770. P200010Guardant360 CDx
  771. P200011ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
  772. P200013Alinity m HBV
  773. P200014cobas® EZH2 Mutation Test
  774. P200015Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
  775. P200016FoundationOne Liquid CDx
  776. P200017ADVIA Centaur Anti-HBe2 (aHBe2) assay
  777. P200018NeuRX Diaphragm Pacing System (DPS)
  778. P200019VENTANA MMR RxDx Panel
  779. P200020SBL-3 Multifocal Intraocular Lens
  780. P200021Neuro Cochlear Implant System
  781. P200022Simplify® Cervical Artificial Disc
  782. P200023Zilver Vena Venous Self-Expanding Stent
  783. P200025ClearVisc Ophthalmic Viscosurgical Device (OVD)
  784. P200026Abre Venous Self-expanding Stent System
  785. P200028DiamondTemp Ablation System
  786. P200029TheraSphere
  787. P200030Gore Excluder Conformable AAA Endoprosthesis (CEXC)
  788. P200031Organ Care System (OCS™) Liver
  789. P200032Occlutech® ASD Occluder and Occlutech® Pistol Pusher
  790. P200035OrganOx metra System
  791. P200036eCoin Peripheral Neurostimulator
  792. P200037ASSURE Wearable Cardioverter Defibrillator (WCD) System
  793. P200039Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular…
  794. P200040SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly
  795. P200041Scoreflex NC Scoring PTCA Catheter
  796. P200044LungFit PH
  797. P200045RelayPro Thoracic Stent-Graft System
  798. P200046Harmony™ TPV System
  799. P200048IsoPSA Assay
  800. P200049Amplatzer™ Amulet™ Left Atrial Appendage Occluder
  801. P210001VENTANA MMR RxDx Panel
  802. P210002therascreen PDGFRA RGQ PCR Kit
  803. P210003ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent…
  804. P210005IC-8 Apthera Intraocular Lens (IOL)
  805. P210006Thoraflex™ Hybrid
  806. P210007Vivistim® System
  807. P210011xT CDx
  808. P210014SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT…
  809. P210015Avive Automated External Defibrillator (AED) System
  810. P210016ManaFuse
  811. P210017Cross-Seal Suture-Mediated Vascular Closure Device System
  812. P210018Et Control
  813. P210019ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2)
  814. P210020Optilume Urethral Drug Coated Balloon
  815. P210022Alinity m CMV
  816. P210025SurVeil Drug-Coated Balloon
  817. P210026Ki-67 IHC pharmDx
  818. P210027QDOT MICRO™ System
  819. P210029Aptima CMV Quant Assay
  820. P210030Roadsaver/CASPER Carotid Stent Device
  821. P210032GORE TAG Thoracic Branch Endoprosthesis (TBE Device)
  822. P210034Agili-C
  823. P210035AccelStimTM Bone Growth Stimulator
  824. P210036PerClot® Polysaccharide Hemostatic System
  825. P210037Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream…
  826. P210039Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch)
  827. P210040RESOLUTION ctDx FIRST
  828. P220002TOPS™ System
  829. P220003PASCAL Precision Transcatheter Valve Repair System
  830. P220004PALMAZ MULLINS XD Pulmonary Stent
  831. P220005CRCDx RAS Mutation Detection Assay Kit
  832. P220006VENTANA FOLR1 (FOLR-2.1) RxDx Assay
  833. P220007Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal…
  834. P220009StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
  835. P220012Aurora EV-ICD System
  836. P220013TactiFlex™ Ablation Catheter, Sensor Enabled™, TactiSys™ Quartz Equipment, TactiSys™…
  837. P220014CraniSeal Dural Sealant
  838. P220015DilightTM (roflufocon E) Overnight Orthokeratology Contact Lens
  839. P220016HepQuant SHUNT® Liver Diagnostic Test
  840. P220020Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
  841. P220021DETOUR System
  842. P220023Paradise® Ultrasound Renal Denervation System
  843. P220024LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh…
  844. P220025LimFlow System
  845. P220026Symplicity Spyral™ Renal Denervation System
  846. P220029Optilume™ BPH Catheter System
  847. P220030UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic…
  848. P220031LimiFlex Dynamic Sagittal Tether
  849. P220032POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
  850. P220034LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus
  851. P230001ColoSense®
  852. P230002Minitouch 3.8 Era System (Minitouch System)
  853. P230003Alinity m HR HPV
  854. P230005Motiva SmoothSilk Round Ergonomix Silicone Gel-Filled Breast Implants, Motiva SmoothSilk…
  855. P230007TriClip G4 System
  856. P230009Shield
  857. P230011TruSight Oncology Comprehensive
  858. P230012UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas…
  859. P230013Edwards EVOQUE Tricuspid Valve Replacement System
  860. P230014Lumicell Direct Visualization System (DVS)
  861. P230015Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC
  862. P230016MAGE-A4 IHC 1F9 pharmDx
  863. P230017PulseSelect™ Pulsed Field Ablation (PFA) system
  864. P230018VENTANA CLDN18 (43-14A) RxDx Assay
  865. P230019MediBeacon® Transdermal GFR Measurement System (TGFR)
  866. P230020Altius® Direct Electrical Nerve Stimulation System
  867. P230021Duo Venous Stent System
  868. P230022Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware…
  869. P230023GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
  870. P230024Flow FL-100
  871. P230025Xstim Spine Fusion Stimulator
  872. P230026Lacrosse NSE ALPHA Coronary Dilatation Catheter
  873. P230030FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter…
  874. P230032AvertD and AvertD Buccal Sample Collection Kit
  875. P230035AGENT Paclitaxel-Coated Balloon Catheter
  876. P230036Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
  877. P230038AbsorbaSeal 5.6.7F Vascular Closure Device
  878. P230040Cordella Pulmonary Artery Sensor System (CorPASS)
  879. P230042Optune Lua
  880. P230043Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™
  881. P230044alfapump System
  882. P240001PearlMatrix™ Bone Graft
  883. P240003Minima Stent System and Minima Pro Stent System
  884. P240004EndoForce Connector for Endovascular Venous Anastomosis
  885. P240005enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic…
  886. P240006VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable…
  887. P240008saypha® MagIQ™
  888. P240009Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic…
  889. P240010MI Cancer Seek
  890. P240011Medtronic Altaviva System
  891. P240012AeroPace® System
  892. P240013Sphere-9 Catheter and Affera Ablation System
  893. P240014MAGiC Ablation Catheter
  894. P240015Womed Leaf Resorbable Adhesion Barrier
  895. P240020TOUCH® CMC 1 Prosthesis
  896. P240021Atellica IM Total PSA II (tPSAII)
  897. P240022EVOLYSSE™ SMOOTH and EVOLYSSE™ FORM
  898. P240023WRAPSODY® Cell-Impermeable Endoprosthesis
  899. P240024Genio® System 2.1
  900. P240026OncoMate® MSI Dx Analysis System
  901. P240027SpineSeal Spine Sealant
  902. P240028WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
  903. P240029CGuard Prime Carotid Stent System
  904. P240031Neuspera Sacral Neuromodulation System
  905. P240033LungFX™ device
  906. P240035ETHIZIA
  907. P240036OmniaSecure™ MRI SureScan™ Lead Model 3930M
  908. P240037VENTANA MET (SP44) RxDx Assay
  909. P240038FINEVISION HP Trifocal IOLs
  910. P240039SetPoint System
  911. P240040Oncomine Dx Express Test
  912. P240042Tendyne Transcatheter Mitral Valve System
  913. P240043DIAM­™ Spinal Stabilization System
  914. P240044Globe® Pulsed Field System
  915. P240045Optimum Infinite (tisilfocon A) Orthokeratology Lenses II
  916. P250002Quest Diagnostics AAVrh74 Antibody ELISA CDx
  917. P250003Embrace(TM) Hydrogel Embolic System
  918. P250004MMR IHC Panel pharmDx (Dako Omnis)
  919. P250005Idylla CDx MSI Test
  920. P250007Zenflow Spring® Implant and Delivery System
  921. P250008Claire™ OCT System
  922. P250009SQUID Liquid Embolic Agent (LEA)
  923. P250010Proliv™Rx System
  924. P250011ProVee System for BPH
  925. P250012Simplera Sync Sensor, Guardian 4 Sensor
  926. P250013aura6000™ system
  927. P250016Belotero® Intense (+) Lidocaine
  928. P250017GORE® VIABAHN® FORTEGRA Venous Stent
  929. P250018RefluxStop® Device and RefluxStop® Deployment Tool
  930. P250019SAPIEN M3 Transcatheter Mitral Valve Replacement System
  931. P250020Belotero Volume (+) Lidocaine
  932. P250021saypha® ChiQ™
  933. P250022Volt™ PFA System
  934. P250023Allurion™ Gastric Balloon System
  935. P250024Trilogy Transcatheter Heart Valve System
  936. P250025TorEx Lung Perfusion System
  937. P250026Atellica IM free PSA II (fPSAII)
  938. P250027Guardant360® Liquid CDx
  939. P250028Synergy Disc
  940. P250029SimpleScreen™ CRC
  941. P250031VENTANA PTEN (SP218) RxDx Assay
  942. P250033NEXUS Aortic Arch Stent Graft System
  943. P250034Optune Pax
  944. P250036PGDx elio tissue complete CDx
  945. P250039LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus
  946. P250041SELUTION SLR™ 014 PTCA Drug-Eluting Balloon
  947. P250042BAGUERA®C Cervical Disc Prosthesis
  948. P250046OncoMate® MSI Dx Analysis System
  949. P250050Liverty™ TIPS Stent Graft
  950. P250051Juveena Hydrogel System
  951. P250055AMDS Hybrid Prosthesis
  952. P260004Signatera™ CDx
  953. P260007Autus Size-Adjustable Valve
  954. P760001AFP RIA KIT
  955. P770001FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)
  956. P770002GONOCOCCAL PILI ANTIBODY TEST
  957. P770005HUNTER-SESSIONS VENA-CAVA OCCLUDER
  958. P780002DARDIK BIOGRAFT
  959. P780005ABBOTT AFP
  960. P780006AMERSHAM AFP
  961. P780007HYDRON HYDROPHILIC CONTACT LENS
  962. P780009BYREL PROGRAMABLE PACEMAKER
  963. P780010PERMALENS (PERFILCON A) SOFT HYDROPHILIC CONTACT LENS
  964. P780011MINI BALLOON
  965. P780012HAVAB
  966. P790002Biomet(R) EBI BONE Healing System
  967. P790005OsteoGenTM Implantable Bone Growth Stimulators
  968. P790006ANGELCHIK ANTI-REFLUX PROSTHESIS
  969. P790007HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
  970. P790010DANKER SILICONE LENS (DIMEFOCON-A)
  971. P790016SALIVART
  972. P790017USCI DILATATION CATHETER
  973. P790018MEDTRONIC(R) HALL PROSTHETIC HEART VALVE
  974. P790019HAVAB-M DIAGNOSTIC KIT
  975. P790020PERMAFLEX (SURFILCON A)(VASURFILCON A)
  976. P790025ABBOTT HBE DIAGNOSTIC KIT
  977. P790027CHAMBER LENS MODELS 101, 101B, 101T
  978. P790028BIOSTATOR GCIIS
  979. P790032GAMMA DAB (125I) AFP RIA KIT
  980. P800002AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB
  981. P800003MODEL 9310 LUNG WATER COMPUTER
  982. P800012DRILAC CUBES{TM}
  983. P800016TENNANT(TM) & KELMAN(TM) TYPE II
  984. P800017CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS
  985. P800019CYBERLITH IV UNIPOLAR PULSE GENERATOR
  986. P800022ZYDERM COLLAGEN IMPLANT (ZYDERM CI)
  987. P800025QUANTITOPE 125I AFP KIT AND CONTROL SERUM
  988. P800027BINKHORST & FEDOROV I IRIS CLIP IOLS
  989. P800029API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM
  990. P800030BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC
  991. P800032BIOSTATOR GLUCOSE CONTROLLER
  992. P800035PERI-OSS
  993. P800036INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4
  994. P800040CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,
  995. P800049MODELS 1S & 1P
  996. P800058N.C.G.T. GRAFT
  997. P800061RIANEN 3H
  998. P800064BIOFLOW(TM)
  999. P800068ENDOTRACHEAL TUBE CHANGER
  1000. P810001MODEL AC (AC1-AC5)

About this dataset

Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.

Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database