Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

Continuing the 510(k) premarket notifications list, 1000 records per page.

  1. K090605CLAMPFIX
  2. K062548MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
  3. K091380CORDCAP
  4. BK120014Test, Qualitative, for HLA, Non-Diagnostic
  5. K791632COMPU-SCAN
  6. K891320ARGELITE 58P (DENTAL ALLOY)
  7. K183190NuStat
  8. K930400TERRA FEMME
  9. K923408WRAPPEL T
  10. K041476GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
  11. K181262SpineJack Expansion Kit
  12. K950040SII 525 APR
  13. K920236CHOLANGIOGRAM CATHETER KIT
  14. K222764LightForce Orthodontic System
  15. K013203BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
  16. K791571TOXOPLASMA ANTIBODY TEST SYSTEM
  17. K813455PUMP & DETECTOR
  18. K230832Powdered Free Sterile Natural Rubber Latex Surgical Gloves
  19. K932421SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE
  20. K843806VIS-1000 VIDEO SYSTEM
  21. K261646Redermax® Antibacterial Wound Matrix
  22. K895356UNIVOX-IC
  23. K160597INDEPENDENCE MIS Spacers
  24. K852400PLAK SMACKER
  25. K071278EMBRACE DUAL CURE COMPOSITE MATERIALS
  26. K033774CT-MASS
  27. K993330THERMOCHEM-HT SYSTEM
  28. K190364CancelleX Porous Titanium Lumbar Interbody Device
  29. K873136MMG CATH-N-PLACE
  30. K080482ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01
  31. K790715ANTISERUM TO HUMAN FC
  32. K861814RHESUS MONKEY SERUM - STERILE FILTERED
  33. K812736SOFTCARE BARRIER WET DRESSING
  34. K183431Medline Digital Rectal Thermometer Sheath
  35. K081322MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL
  36. K2301796440 MyLabX90
  37. K013052KONICA LASER IMAGER, DRYPRO MODEL 751/752
  38. K861750CK/LD BUFFER (CAT. NO. 5808)
  39. K992956LUCITONE FRS FLEXIBEL DENTAL RESIN
  40. K905413JUZO-RESPIRA ANTI-EMBOLISM STOCKING
  41. K051258KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
  42. K930895SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF
  43. K093037PENTEX EC-3890LI
  44. K082554KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600
  45. K800950TANIT HOME SUNTANNING UNIT
  46. K780427RP-510/RP-514 PARALLEL PLATE DIALYZERS
  47. K253367EliA CTD 13 Screen
  48. K132804ACUSON S1000 / S2000 / S3000
  49. K932936L.A.P. II SPRIOMETRY SYSTEM
  50. K971794ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE
  51. K914614FRAMES (SPECTACLES) VARIOUS TYPES
  52. K853493REUSABLE BULLET NOSE CUTTERS IN 3.5 & 4.2MM CONFIG
  53. K862751USA ASPIRATOR
  54. K963338UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH
  55. K103298ACAM 5 AUDIOMETER SYSTEM
  56. K884556DREYER CURVED ENDOILLUMINATOR
  57. K781854PAD, B-D I.V. CATH.
  58. K193203MOJAVE Expandable Interbody System
  59. K973158ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE
  60. K202543OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…
  61. K871387SECOND NATURE(TM)
  62. K910747FORTRESS AEROEDGE 3-WHEEL MANUAL RACING WHEELCHAIR
  63. K242415TMC Compression Implant System
  64. K112999DIMENSION CLINICAL CHEMISTRY SYSTEM
  65. K910464GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE
  66. K232208Sectra Digital Pathology Module (Version 3.3)
  67. K093428SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
  68. K901819MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
  69. K130936AERODR SYSTEM WITH P-31
  70. K854752THE CALIFORNIA SPLINT
  71. K870246REFLOTRON(R) AST (GOT)
  72. K821494RIA STAT 16
  73. K921403MODEL 654 ANALYZER
  74. K161718MaxBlend 2, MaxBlend Lite
  75. K192199CRC PC Smart Chamber K1
  76. K963139OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
  77. K092790POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
  78. K942459CURASALT HYPERTONIC SALINE DRESSING
  79. K893945FD 350 DENTAL STOOL
  80. K063275DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT…
  81. K042171AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232
  82. K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
  83. K072071STRAUMANN P.004 CEMENTABLE ABUTMENTS, TEMPORARY COPINGS AND PROTECTIVE CAPS
  84. K822033BERMAN ANGIOGRAPHIC BALLOON CATHETER
  85. K792710PARA-PAK CLEAN VIAL
  86. K801686SPACELINE THREE WAY SYRINGE
  87. K811943MACHIDA NASOPHARYNGO-LARYNGOSCOPE
  88. K162960TotalC-Ram
  89. K200242StaClear Syringe
  90. K884833ULTRA 2000 (T.E.N.S.)
  91. K261610Verge™ Microcatheter
  92. K100954ADAPT, MODEL AX-03SN
  93. K822745THE SCREENING TYMPANOMETER
  94. K931882MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR
  95. K092933SAF (SELF ADJUSTING FILE)
  96. K131937VOLUSON I/E
  97. K900494SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM
  98. K974651ABBOTT AXSYM SYSTEM
  99. K944778LATEX EXAMINATION GLOVES
  100. K000864INTRASTENT DOUBLESTRUT XS STENT
  101. K001266VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK…
  102. K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
  103. K915227GEN-X 800/500
  104. K952524AESCULAP BIOPOLAR COAGULATOR
  105. K050474VEINNOVATIONS INFILTRATION SYSTEM
  106. K830340FITKIT I CHECKUP KIT
  107. BK840019Solution, Copper Sulfate for Specific Gravity Determination
  108. K820253SIMUL-FER SERUM IRON TEST KIT
  109. K922084MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM
  110. K982604LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM
  111. K121470FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR
  112. K891731PATIENT EXAMINATION GLOVES (LATEX)
  113. K991636ELEKTA STEREOTACTIC GUIDE
  114. K070631DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM
  115. K124024APD LUER-LOCK ADAPTER
  116. K892246CHAMP-PAQ VINYL PATIENT EXAMINATION GLOVES
  117. K780231BANDAGE, ELASTIC
  118. K850143SPORDEX CULTURE MEDIA
  119. K823664UNIVERSAL SLING, SLING & SWATHE
  120. K200970Self-Contained Biological Indicator
  121. K913129ANGIOLAZ ANGIOSCOPE CATHETER
  122. K102643SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT
  123. K920454CLEARTRAC CANNULA
  124. K241229Hello,eyes® BIO Plug
  125. K034005SDS-4I
  126. K910716MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE
  127. K944398SUNGLASSES
  128. K841561HESUNG'S BLOOD DONOR SETS
  129. K864881ARTHROSCOPIC ANKLE HOLDER
  130. K890246ARTERY FORCEPS
  131. K830145PANTY-LINERS UNSCENTED
  132. K043241LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
  133. K771484RINSE BLOCK ASSEM, D-W PERI. DIALYSIS
  134. K013303CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE…
  135. K141547WINGMAN EXTENDABLE TIP SUPPORT CATHETER
  136. K021580OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05
  137. K091968KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
  138. K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus…
  139. K915327ELITE II ELECTROCARDIOGRAPH,MODIFIED
  140. K131549CHEMOLOCK, CHEMOLOCK PORT
  141. K213158Syringe with permanently attached needle
  142. K191741Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape
  143. K042899SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
  144. K902109STATLOCK IV CONNECTOR AND ANCHOR SET
  145. K925313TITANIUM COC ABUTMENT HEADS FOR IMZ
  146. K120948PREXION 3D
  147. K182363BTL-703
  148. K222994Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
  149. K233895EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA…
  150. K812360PRECIOUS-METAL/PLASTIC ATTACH., AUXILL
  151. K902514CHALLENGE 5010 POWERED MUSCLE STIMULATOR
  152. K910610INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT
  153. K852020INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI
  154. K944978BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI
  155. K103564VENOFER PUMP
  156. K980741BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)
  157. K000174ACTION AF-1 WHEELCHAIR
  158. K923941IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE
  159. K842045WOODLYN CLASSIC EXAM. CHAIR
  160. BK040072Blood Establishment Computer Software and Accessories
  161. K001010ASCENT KNEE REVISION FEMORAL STEM
  162. K050162CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
  163. K222275Saige-Density
  164. K990833DOSE CALC, MODEL VS. 1.02
  165. K780959MUELLER HINTON AGAR WITH THYMIDINE
  166. K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
  167. K812296GAMMA GLUTAMY TRANSPEPTIDASE
  168. K130906ENDOFLIP CATHETER
  169. K810533CIRCLE NEPHROSTOMY TUBE INTRODUCER
  170. K932057BROWNE TST SINGLE USE BOWIE DICK TYPE TEST PACK
  171. K972752DURACON CONVERSION METAL BACKED PATELLA
  172. K031156NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005
  173. K963178ELECSYS CALCHECK T4
  174. K250314Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
  175. K802579CYBREX TM FPQ FLUORESCENE POLARIZATION
  176. K210805Ceribell Instant EEG Headband
  177. K160371NovaPACS
  178. K113008KODAMA INTRAVASCULAR ULRASOUND CATHETER
  179. K991211EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
  180. K991914SUPER SOOTHER
  181. K931495ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT
  182. K930975DERMA-LASE DLA-1 LASER
  183. K850005VISOPROTECT OCCULAR SHIELD
  184. K100862BODYFLOW P2CH
  185. K242091Bolo Button System
  186. K181696ChitoZolve
  187. K012558POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING…
  188. K852612METRONIC MODEL F7700 HEART VALVE SIZERS
  189. K180028Cook 810 Set, Desilets-Hoffman Introducer Set
  190. K844054CANON AUTO KERATOMETER K-1
  191. K891159SODIUM BICARBONATE, U.S.P.
  192. K861002VISION SGPT (ALT)
  193. K941410CHIN HSIEU CHENG
  194. K973128OLYMPUS NA-10J-1 ASPIRATION NEEDLE
  195. K851678OSTOMY BAGS URETHEROSTOMY
  196. K812473HEAD PROTECTOR
  197. K820763ENZYM-LINKED T3
  198. K860721BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST
  199. K120245PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
  200. K874154ELECATH(R) TRANSESOPHAGEAL PACING CATHETER
  201. K130196SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP…
  202. K882374WAKO(TM) CRP
  203. K913502PHONAK AUDINET PP-C-P BTE HEARING INSTRUMENT
  204. K921310CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER
  205. K895672TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
  206. K142394Masimo Root Monitoring System and Accesories
  207. K183433FUJIFILM Ultrasonic Endoscope
  208. K061323MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM
  209. K780862MODEL 290 OXYGEN RICH AIR SUPPLY UNIT
  210. K1134423DI
  211. K895983MULTISTIM PLUS
  212. K902392COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL
  213. K062896V2 TREATMENT SYSTEM (V2 CONSOLE, V2 ICE PROBE, V2 DEWARS) MODELS; VS3000, VP0600, VD0600
  214. K152572AXIOS Stent and Delivery System
  215. K090869MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA…
  216. K864506SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1
  217. K934409POWDER FREE LATEX EXAMINATION GLOVES
  218. K935755THE ULTRA
  219. K841163CONTACT LENS INSERTER/REMOVER
  220. K920927KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024
  221. K032943STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
  222. K905265620 FLUOROSCOPIC TABLE, TILT OR POWER MEDICAL TAB
  223. K860801MODEL 8400 W/MODIFICATIONS (SPECTRUM 32)
  224. K220696uCerv Flux-C 3D Porous Titanium Cervical Interbody
  225. K853740KAY PLUS ADULT DIAPER
  226. K223399AViTA Pulse Oximeter
  227. K935362P-AMYLASE CONTROL
  228. K770498PRESERVE LUBRICANT CODE NO. 43=4035
  229. K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158…
  230. K003510INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
  231. K892993NON-STERILE LATEX EXAMINATION GLOVES
  232. K936086STERILE VIDEO CAMERA COVER AND DRAPE
  233. K780623ENDOCARDIAL ATRIAL PACING LEAD, M. 6994
  234. K213135Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor…
  235. K952483LEEP SYSTEM 1000
  236. K991546AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD
  237. K102625VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
  238. K872070CHROMOTITRE E.I.A. TOXOPLASMA IGM
  239. K821559LEVEL I LIPID CONTROL
  240. K945714VERABOND III
  241. K974587H2O
  242. K160211Wet Original Personal Lubricant
  243. K921139HEALEY REVISION COMPONENT SYSTEM
  244. K902408DIAGNOSTIC ULTRASOUND UFS 1005
  245. K801952SPINE ALIGN
  246. K200479AquaPulse Auxiliary Water Connector
  247. K181345Image Filing Software NAVIS-EX
  248. K082249MORPHEUS
  249. K210859NextAR™ Spine Platform
  250. K951456SCIPOTEX (BLUE)
  251. K191619TurboTemp EZ
  252. K771247CORE MATERIAL
  253. K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
  254. K844377SILICONE
  255. K190672StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
  256. K890024SARNS VENT CATHETER
  257. K011745HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
  258. K980554ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED…
  259. K012355IMAGE-X SYSTEM
  260. K233439HD60 Series Ultrasound Diagnostic System
  261. K891886SCISSORS, VARIOUS TYPES
  262. K971478DURALASTIC ANATOMICAL CHIN IMPLANTS
  263. K003154MIZAR, BASIS BE, SANDMAN DIGITAL
  264. K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail…
  265. K180051XSTAT 30, 1-Pack
  266. K882145PHOTO-CURING LIGHT
  267. K042924ARCHITECT STAT MYO IMMUNOASSAY
  268. K071310SYNGO CT ONCOLOGY SOFTWARE PACKAGE
  269. K181026OsteoBridge™ IDSF System
  270. K934028STERILE DRESSING CHANGE TRAY
  271. K905197THE BRACKET ASSEMBLY WITH A SECURITY SYSTEM
  272. K201175StealthStation Cranial Software v1.3.0
  273. K063682INTRALASE FUSION LASER
  274. K893594LATEX EXAMINATION GLOVES
  275. K920177VERSA-VIAL
  276. K972314PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND…
  277. K994258SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE…
  278. K100646AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
  279. K021999GRIPPER PLUS NEEDLE
  280. K831297PROTOTRO/PROTEOLYTIC ENZYME CONTROL
  281. K883311COUNT-A-DOSE
  282. K242248Introducer Sheath Kits
  283. K903834N. M. BEALE COMPANY VU-THRU WATER BOTTLE
  284. K221309AI100 with Shonit
  285. K844848IMA-TROL IMMUNOASSAY CONTROL
  286. K132225EXTRICARE
  287. K062115CARBON DIOXIDE MONITOR, MODEL OLG-2800A
  288. K950880AOI UNIVERSAL ULTRASONIC HANDPIECE
  289. K981015PALI-TRODE
  290. K831818CENTRAL STATION MONITOR CSM-100
  291. K020328MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)
  292. K850046PROFESSIONAL SUPPLIES, INC.LENS CARRYING CASE
  293. K974050SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
  294. K901537MODIFIED OPUS PHENOBARBITAL TEST SYSTEM
  295. K012096DISPOSABLE VITRECTOMY LENS
  296. K262200Stone Clear (BWSC-LP9-02)
  297. K180025Centurion POCT System
  298. K011981MHS 5000
  299. K162598HAPI Seal
  300. K832902MIDDLEBROOK ADC ENRICHMENT
  301. K042591SMARTMIX PRE-FILLED MIXING SYSTEM
  302. K911997TENDERFOOT(R), MODIFICATION
  303. K001516PASCO MIC AND MIC/ID PANELS
  304. K890189AGEN DIMERTEST EIA
  305. K852485CELLGRO(ISCOVE'S MEDIUM) MODIFICATION
  306. K141143COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C…
  307. K813568ESTILUX POSTERIOR XR
  308. K210253Best Glove-Latex Powder Free Examination Glove
  309. K811944GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER
  310. K171624IXOS Radius Plate System
  311. K880976AL-200B MUSCLE ACTIVITY INTEGRATOR
  312. K905379AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP
  313. K201971SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
  314. K072858TC-PLUS PRIMARY KNEE SYSTEM
  315. K840177APPOSE ULE STERILE DISPOS. SKIN STAP
  316. K990632OPTICAL TRACKING SYSTEM (OTS)
  317. K260850OSTEOMNI SPINAL CAGES SYSTEM
  318. K953453SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
  319. K971869FINESSE ALL-CERAMIC SYSTEM
  320. K930929ESOPHAGEAL STETHOSCOPE
  321. K891723PATIENT EXAMINATION GLOVES (LATEX)
  322. K052117I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
  323. K200282Orfit Aerial Couchtop
  324. K897009PALFIQUE LIGHT BONDING AGENT
  325. K141593UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH
  326. BK890017Container, Empty, For the Collection '& Processing of Blood/Blood Components
  327. K761255DIGITAL THERMOMETER
  328. K243029Origin™ TT Stem
  329. K844733KONTRON MINIMON 7131 PATIENT MONITOR
  330. K172986Zmachine Synergy
  331. K782088MONITOR, HEART RATE MODEL 105
  332. K982807POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
  333. K111697AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
  334. K140351ARROW GPSCATH BALLOON DILATATION CATHETER
  335. K082750ENTACT SEPTAL STAPLER, MODEL 610-00100
  336. K8943228400ST VOLUME VENTILATOR
  337. K914034INFUCARE SYRINGE PUMP TUBING SET
  338. K800868FERRO-QUANT TM FE 59 TEST KIT
  339. K131464EXTRICARE NPWT FOOT DRESSING
  340. K841166HEPARIN LOCK FLUSH PROCEDURE PACK
  341. K780527CORTRAL I
  342. K812893SUPERFLAB
  343. K842155SERUM IRON & SERUM IRON BINDING CAPACI
  344. K915561ZEISS MULTIYAG LASER
  345. K844044LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER
  346. K964181SPONGETRAC
  347. K131224SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL…
  348. K770078CASTLE TEC-TEST STEAM STERI. INTEGRATOR
  349. K980473PRESS-FIT STEM
  350. K003206GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
  351. K023521EASY LIFE
  352. K841205NON PROPAGATING TRANSPORT
  353. K173699The Pump by Babyation
  354. K000197CORTEK CYSTOSCOPE
  355. K890735COATED APEX PROBE
  356. K251015APRO 45 Catheter and Alembic Aspiration Tubing
  357. K895031MODIFIED INFANT NASAL CANNULAE ASSEMBLY
  358. K910839ULTIMATE 3000
  359. K971334PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
  360. K954801TECHFIL
  361. K101592ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
  362. K8029146-435 FILTER PAD, 5/PKG.
  363. K072665SUNIRAY 5.2
  364. K896494ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST
  365. K850873HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL
  366. K252013EnSite™ X EP System
  367. K962901OLYMPUS B5-2C/B7-2C BALLOON CATHETER
  368. K151204HEMO-Bandage
  369. K925124TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST
  370. K211139CUBE Air Purifier
  371. K830234CONTOX HEAVYMETALS CONTROL
  372. K852128NORELCO ELECTRONIC DIGITAL BP METER HC3501
  373. K900862DAHLBERG MODEL JM IN-THE-EAR HEARING INSTRUMENT
  374. K925163MICODOSE CHLORHEXIPREP
  375. K903350PROLAX DISPOSABLE LATEX GLOVES (EXAM) HYPOALLERGEN
  376. K950328AMOXICILLIN/CLAVULANIC ACID 2/1
  377. K812133WOUND CLOSURE INSTRUMENT TRAY
  378. K873593BIOSURE SPECIMEN COLLECTION CONTAINER
  379. K232725Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor
  380. K173839Tissue of Origin Test Kit-FFPE
  381. K902610GENERAL ELECTRIC AMX 3
  382. K021242PORTALLOY 54
  383. K910483MONOTUBE EXTERNAL FIXATION SYSTEM
  384. K980509DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS
  385. K851225URINE DUO
  386. K060071NEXA COMPRESSION SCREW
  387. K910989OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP
  388. K142600VIAL-MATE Adaptor
  389. K895982WIDEX HEARING AID MODEL ES 10 ASP T
  390. K163699ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular…
  391. K211714Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy)
  392. K021517ABP FOR WINDOWS
  393. K233458CM005 Standard (CM005); CM004 Mini (CM004)
  394. K910911MOSS P.E.G. TRAY
  395. K780420GENERATOR, PULSE, CARDIAC, IMPLANTABLE
  396. K974054DISTAL CENTRALIZER, EXETER II HIP SYSTEM
  397. K182147CTXX85
  398. K953876PENTAX ULTRASOUND ENDOSCOPE MODEL FG-32UA (MODIFICATION)
  399. K002053NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
  400. K890365SEPTUM ELEVATOR
  401. K100462JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
  402. K023955BD VIPER INSTRUMENT
  403. K910786TROCAR (FALLER STYLET)
  404. K935881SPECIALTY SPONGES
  405. K031459RAPIDO CUT-AWAY CUTTER
  406. K10372410 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)
  407. K241649DUO1 and DUO2
  408. K201700BEGO Semados® RS/RSX Implant System
  409. K002257TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100
  410. K022355QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61
  411. K890196MICROTRAK CHLAMYDIA EIA
  412. K911916ACUSON C366 TRANSDUCER
  413. K191433AGILON® XO Shoulder Replacement System
  414. K980165INFUTEST 2000 INFUSION DEVICE ANALYZER
  415. K060174SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM
  416. K881289CORIN BIPOLAR PROSTHESIS
  417. K832463RAICHEM ALKALINE PHOSPHATASE REAGENT
  418. K935400FONIX 3500 HEARING AID ANALYZER
  419. K152671Pulse Aloe-ahh
  420. K993568MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L
  421. K840413CEMENT RESTRICTOR
  422. K921496SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
  423. K141689FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…
  424. K020481PULPDENT POST CEMENT
  425. K131615POLARIS SPINAL SYSTEM
  426. K240913Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)
  427. K963336HARMAC THERMODILUTION CATHETER
  428. K941098SECURE-SITE
  429. K861415CANON AUTO REF KERATOMETER RK-1
  430. K121174XPRESS MULTI-SINUS DILATION TOOL
  431. K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…
  432. K880235INTELECT MODEL 120
  433. K923045SENSITITRE SUSCEPTIBILITY PLATES
  434. BK070035Blood Establishment Computer Software and Accessories
  435. K970954O.B. APPLICATOR TAMPONS
  436. K123220VERTEX THERMOSENS RIGID
  437. K110864BIOSPINE VBR SYSTEM
  438. K173408Mammomat Revelation
  439. K981485HYBRID CAPTURE II GC-ID
  440. K011718BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
  441. K911338LIMA CEMENT RESTRICTOR
  442. K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
  443. K231595Electric Breast Pump
  444. K072067N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
  445. K091732VRLXP, MODEL XP
  446. K000144NIPRO INSULIN SYRINGE
  447. K843760UROPAPER EIKEN G
  448. K801956TISSUE-TEK III TISSUE EMBEDDING CENTER
  449. K082211RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
  450. K952742BLOOD UREA NITROGEN REAGENT SYSTEM
  451. K844719360 INFUSER
  452. K923735SOUNDCHOICE K-AMP
  453. K971825PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
  454. K132005RETROGRADE FEMORAL NAIL
  455. K133699POWDER FREE GREEN, BLUE AND BROWN POLYCHLOROPRENE EXAMINATION GLOVES
  456. K011986SAFE-STEER GUIDE WIRE SYSTEM
  457. K210693PLEXR PLUS
  458. K781220ANTI-HUMAN LAMBDA SERUM
  459. K143271CastleLoc-P Anterior Cervical Plate System
  460. K110558CS1000 LIGHT THERAPY DEVICE
  461. K210286Cure 2.0 Anterior Cervical Plate (ACP) System
  462. K022338OPTICAL INTEGRITY GENERAL SHAPED FIBER
  463. K970352SMARTVAC SMOKE EVACUATION SYSTEM
  464. K900829BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC
  465. K092341LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION
  466. K032156ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER…
  467. K831946SURGICAL DRILL-ELECTRIC-HANDPIECE
  468. K980238GYNEX EXTENDED REACH NEEDLE
  469. K991675MODIFICATION OF: STERRAD BI TEST PACK
  470. K990040CLEARFIL SE BOND
  471. K222541Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
  472. K003633DW 277 #4
  473. K896029DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20
  474. K914737ASL MODEL #104
  475. K072261FINESSE SYSTEM
  476. BK170099Automated Blood Cell Separators
  477. K872886CARBON DIOXIDE
  478. K021500VACUUM ASSISTED CLOSURE
  479. K885155MENTOR MDS
  480. K002991ZAP DUAL CURING LIGHT
  481. K842540CLINICOMP R.C.I.
  482. K210362s-Clean Pre-Milled Abutment
  483. K760189STOPCOCK, WATERLINE
  484. K942962GGT QVET
  485. K050244MALE NATURAL RUBBER LATEX CONDOM
  486. K140333ASCEND
  487. BK120026Platelet And Plasma Separator For Bone Graft Handling
  488. K896184KALOS 05 PULSE GENERATOR
  489. K922182UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
  490. K171249Entrada™ hip stem
  491. K854227FASCILULATED NAIL
  492. K832869MOTILITY MEASUREMENT SYS MMS-100
  493. K850679TRYPSIN-EDTA SOLUTION
  494. K896670TIP TOP(R) DISPENSER CAPS
  495. K150254Streamline OCT Occipito-Cervico-Thoracic System
  496. K172382GC Fuji Direct
  497. K070178AESCULAP RESORBABLE PIN, MODEL FR735
  498. K112653ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEMS
  499. K981269UNIVERSAL DRIVE SYSTEM
  500. K023120OXYCON MOBILE
  501. K193008Tricoglam Home Use
  502. K831625UREA NITROGEN-BUN-REAGENTS B6360-12
  503. K920789B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER
  504. K240463Slow Wave DS8 (SWDS802)
  505. K221534Surgical Face Masks (Ear Loops And Tie-On)
  506. K980784SURETOUCH
  507. K890125SANITARY NAPKIN PADS
  508. K023732CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
  509. K072402FLEX-STAR V
  510. K963743MANAN PROSTATE UNI-LOCK
  511. K040484MAXO2+, MODEL A AND AE
  512. K231920Longeviti ClearFit OTS Cranial Implant
  513. K843395ENCORE TSH REAGENT
  514. K781384WRIGHT RAPID STAIN
  515. K943135MED-SAFE INSULIN SHARPS CONTAINER
  516. K853324DAHLBERG EB BEHING-THE-EAR HEARING AID
  517. K853992VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &
  518. K870717SPOTTEST MICRODASE
  519. K250037Incompass Total Ankle System
  520. K881469ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL
  521. K200354Electronic stimulator
  522. K060190SUPER SHEATH XL INTRODUCER SHEATH
  523. K043418COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
  524. K100474QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W
  525. K101305ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL
  526. K093593CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI…
  527. K904491TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
  528. K903524HORIZON 2000 ST ANALYSIS OPTION
  529. K780805S/D 600 SPHYGMOMANOMETER AND PULSEMETER
  530. K012035BRAUN PRECISION SENSOR PRO, MODEL BP 2590
  531. K021617C.T.M. POWER CHAIR, MODEL HS-2800
  532. K221219syngo.CT CaScoring
  533. K222068Durex Penck III Regular
  534. K813218TDX VANCOMYCIN
  535. K894340PCI MODEL 2041-A TELEMETRY MONITOR
  536. K862332ANAEROBE RAPID CHROMOGENIC ID PANEL
  537. K110978ONESTEP PEDIATRIC MFE'S
  538. K812467PGUA-INDOL MICROTUBE
  539. K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL
  540. K900031MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
  541. K942189CRYSTAL EAR
  542. K173826THP Hip Fracture Plating System
  543. K900844WEDJETS
  544. K802325CRITERION II PACING SYSTEM MONITORS
  545. K823684FILE TYPE K ENDODONTIC
  546. K101635TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM
  547. K121401TENDER TOUCH
  548. K953375NG SECURE
  549. K973831PRE-POWDERED PATIENT EXAMINATION GLOVE
  550. K021986BRAINET
  551. K771573DUO-CATH FEMORAL
  552. K993657ACUMED SUTURE ANCHOR
  553. K180962KLS Martin Individual Patient Solutions
  554. K961858COSGROVE DEPTH ELECTRODE KIT(CDEK)
  555. K851717880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR
  556. BK860039Kit, Test, Quality Control Kit for Endotoxin
  557. K050777PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
  558. K894299REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
  559. K901122TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE
  560. K983511SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER…
  561. K955592COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
  562. K863044CAPILLARY FLOW HOLLOW FIBER DIALYZERS
  563. K993793GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
  564. K902235LVM QUALITY CONTROL SERUM
  565. K972876GLUCOTREND BASIC SYSTEM
  566. K081695DMC COMPOSITE
  567. K101945NEODENT IMPLANT SYSTEM
  568. K8539361351 UROFLOW AUTO START
  569. K940263NPH-KLENZ
  570. K073280BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5
  571. K110587CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL…
  572. K955006ECLIPSE 2100
  573. K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)
  574. K150700ACP 1 Anterior Cervical Plating System
  575. K192484Fixone Biocomposite Anchor
  576. K081273ULTRACAPS S
  577. K033841RESMED S8 PRIME CPAP SYSTEM
  578. K180429Advincula Delineator Uterine Manipulator
  579. K934928INSITE FILTER & TUBING SET
  580. K171954ClearLine IV
  581. K790416DIATEK 500
  582. K903865ITE HEARING AID, SOUND MED AMETHYST MODEL
  583. K913829OLYMPUS FLEXIBLE TIP THORACOSCOPE
  584. K851843OSMOCEL 3
  585. K791747HTSH NEONATE RIA DIAGNOSTIC KIT
  586. K103052V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE
  587. K833606IMPLANT MEASURING GAUGE
  588. K801546THE SIMPLICITY PUMP #2100 INFUSION PUMP
  589. K130406DIAGNOSTICPRO EDGE
  590. K955719SICKLE-2000
  591. K873151MODEL 7200A, PRESSURE VENTILATION OPTION
  592. K131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
  593. K130549INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
  594. K913320MIL CM-II COAGULATION MACHINE
  595. K893814SURGICAL INSTRUMENT KIT, DISPOSABLE
  596. K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material
  597. K940151ULTRASOUND PROBE DRAPE
  598. K070673FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE
  599. K811457MODEL RS-8100
  600. K953824LIFEMASK FACE SHIELD
  601. K001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
  602. K850753NATURAL MOTHER BREAST PUMP
  603. K090505SPEQ ULTRASOUND SYSTEM
  604. K191051ARGOS
  605. K101594POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
  606. K052841MIRA-FLEX 18 MICROCATHETER
  607. K914782SUCTION/IRRIGATION PROBE
  608. K141747RHINOGUARD
  609. K102084STIMPOD NMS450 NERVE STIMULATOR
  610. K892878KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000
  611. K863985EVOPORT 100
  612. K031465MODEL 2100 PULSE OXIMETER
  613. K926168SILK SUTURES-REVISED LABELING
  614. K884196SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)
  615. K202449Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs…
  616. K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…
  617. K960174UNIMARK MIDSTREAM PREGNANCY TEST STICK
  618. K040909SONO TT ULTRASONIC FLOWCOMPUTER
  619. K151088DMRC Bulk Fill
  620. K190118Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
  621. K874893MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR
  622. K790646HELENA QUIPLATE SYSTEM
  623. K230025IVYLASER Handhold Hair Removal Machine
  624. K020371UPLINK TEST SYSTEM
  625. K951932OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
  626. K112129VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
  627. K893441ARGENCO 50 TYPE III DENTAL GOLD ALLOY
  628. K182825FUJIFILM Ultrasonic Endoscope
  629. K002631ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
  630. K934210HEMOLAB PROTEIN C CHROMOGENIC ASSAY
  631. K863746BIRD NIGHTBIRD NASAL CPAP SYSTEM
  632. K082339ENABLER-P SUPPORT CATHETER
  633. K072148CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
  634. K880512DRUG MIXTURE CONTROL IN URINE
  635. K083448CABLE, TRANSDUCER, MODEL 2400GN
  636. K042356SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
  637. K842460VF-PD-120
  638. K945792IM512P
  639. K080780ANCHORAGE SCOPE, MODEL 000003
  640. K051739POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER…
  641. K934271BECKMAN SYNCHRON LACTATE REAGENT
  642. K883784TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE
  643. K121843NP-CAST ABUTMENT SYSTEM
  644. K171587VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
  645. K000728MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
  646. K910974MCCONNELL SHOULDER BRACE
  647. BK980042Device, Warming, Blood and Plasma
  648. K781325MARKII VENTIMASKS
  649. K090445ATMOS C361/C451 SUCTION PUMP
  650. K201563PuRE PMMA Disc
  651. K240879EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
  652. K063632X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
  653. K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
  654. K920548SHARPE ENDOSCALPEL
  655. K932232PROFESSONAL HI-LOW WORK TABLE MODEL 3400
  656. K842632DILATOR/SHEATH SET
  657. K902092RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY
  658. K033256ATHENA PELVIC MUSCLE TRAINER II
  659. K841881EASY EYES TM LENS CARRYING CASE
  660. K873224BRAIN HEART INFUS AGAR W/5% SB & GENTAMICIN-#P3772
  661. K833976VANISH
  662. K874044INTRA-ARTICULAR ARTHROSCOPIC SHAVER
  663. K981665SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE
  664. K212839Opulent TiNbN Coated Knee
  665. K864474DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC
  666. K182228MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
  667. K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro…
  668. K901137CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)
  669. K895995RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES
  670. K231479TriALTIS Spine System
  671. K971988ALLEN, ULTRA AND SMART SOCKETS
  672. K832221YBBOTT CMV TOTAL AB EIA
  673. K080012PLATELIA LYME IGG ASSAY
  674. K822236FRANKLIN QUANTIC 1200
  675. K162128Scope Buddy Plus Endoscope Flushing Aid
  676. K870925PAD, BED LINEN PROTECTIVE
  677. K110397TRUMATCH PERSONALIZED SOLUTIONS
  678. K961883VERSA-CATH ARTERIAL CATHETER
  679. K800336GAMBRO LUNDIA FIBER
  680. K253423ToeJack MIS Bunion System
  681. K011206PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES
  682. K882873FIELDTEX HEMATOXYLIN
  683. K111657AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE
  684. K923842BISCO UNIVERSAL BOND-3
  685. K163670Rampart One Lumbar Interbody Fusion Device
  686. K024209QWH-250-PAN WRIST ARRAY COIL
  687. K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
  688. K970764COMEG ENDOSCOPY RESECTOSCOPE ACCESSORIES
  689. BK960053Test, Qualitative, for HLA, Non-Diagnostic
  690. K253612Acclarent AERA Eustachian Tube Balloon Dilation System
  691. K900323PERITONEAL DIALYSIS CYCLER SET
  692. K953884PROPHET
  693. K040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
  694. K250020Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9)…
  695. K230026SQUALE
  696. K182626OEC One
  697. K904096PHOTAC-BOND
  698. K881151MICROSCRAPE
  699. K931880PROFILL LC COMPOSITE
  700. K070155INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D…
  701. K801888HANDPIECE, DENTAL
  702. K770735DIALYZER, COIL, CD, LSA, 5M1765
  703. K831693MAXI PADS SCENTED DEODORIZED
  704. K200190ScalpelCric
  705. K013891SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
  706. K983972IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
  707. K935116EMIT IIC BARBITURATE ASSAY
  708. K840015SWIVEL ADAPTOR W/ALARM PORT
  709. K031122HEMOSIL FACTOR X DEFICIENT PLASMA
  710. K232827LightForce Orthodontic System
  711. K935437ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES
  712. K112629ONSET ACCESS CATHETER SYSTEM
  713. K934923CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET
  714. K873627CTI STRAIGHT STEM
  715. K913611COWBOY
  716. K153553SiO2 Coated syringe 3 ml
  717. K974098PUBOUURETHRAL SLING
  718. K172109Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
  719. K933516ACU-E PUNCH
  720. K950141SCIMED(R) CHOICE(TM) PTCA GUIDE WIRE
  721. K082285EASY GLAZE
  722. K945956STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS
  723. K833970MICRO-STRUCTURED HS2P HIP STEMS
  724. K945868R&D PART NOS. 5262, 5543, 5432, 5469
  725. K860083DERMASCAN LASER SURGICAL HANDPIECE
  726. K955251OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
  727. K961129AREMA II
  728. K240378FAQ™ 201, FAQ™ 202
  729. K894528FPR PHENYTOIN CALIBRATOR KIT
  730. K974199ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTION
  731. K862791MP-30XM-IE FACE MASK AND FILTER KIT
  732. K920869FLOW DIRECTED THERMODILUTION BALLOON CATHETER
  733. K851160VAN-TEC GUIDE WIRE W/HYDROMER COATING
  734. K810994AMES TDA TM PHENOBARBITAL TEST
  735. K962366HEARTPORT CABLE BULLDOG CLAMP
  736. K861059DAKO ITA SYSTEM
  737. K043352GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR
  738. K933868ANGIOLAZ VIDEO ENDOSCOPIC SYSTEM MODEL CAMLUM1 AND ACCESSORIES
  739. K860645ELECTROPHORESIS DATA CENTER (EDC)
  740. K103668BNX FINE NEEDLE ASPIRATION SYSTEM
  741. K030284POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
  742. K240853Pathfinder® CR System
  743. K021446OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH…
  744. K973908AUKLET CT SCANNER, TSX-003A
  745. K964111LITHOVAC SUCTION/ASPIRATION PROBE
  746. K901917DUAL CEMENT
  747. K851867DAHLBERG MODEL DD BEHING-THE-EAR HEARING AID
  748. K897021MARTIN-HENSLEY SEGMENT LENS
  749. K810856DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT
  750. K252314Arthrex SutureTak Suture Anchor
  751. K101985ASAHI GUIDE WIRE EXTENSION 165CM
  752. K935832CHROMOPHARE
  753. K081868SMART LEISH, MODEL LGM1-050
  754. K004032PERFECTA AND EXTEND
  755. K935918SPECTACLE FRAME
  756. K140796MEDUSA VASCULAR PLUG,
  757. K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated
  758. K163185OptiLux LED Illuminator
  759. K140693VSCAN WITH DUAL PROBE
  760. K926454ANESTHESIA RESPIRATORY BREATH CIRCUIT PACKS/COMPON
  761. K894265DSL 17A-OH PROGERSTERONE (DSL #6800)
  762. K782048TEST KIT, IIF-ANA
  763. K871291AM CATH ESWL STENT
  764. K060828MODIFICATION TO ENDOTINE RIBBON
  765. K770243ELGILOY STYLET
  766. K851579CHOCOLATE MUELLER HINTON AGAR
  767. K240621Morpheus® Moldable; Agilon® Moldable
  768. K820242DIGICUFF
  769. K864896MEDICOMP INHALANT MASK ELBOW
  770. K960956STERNGOLD M-PF YELLOW CROWN & BRIDGE ALLOY MODEL 1127200
  771. K913684DAVOL POST-OP AUTOTRANSFUSION SYSTEM
  772. K132164HEARTSPAN STEERABLE INTRODUCER KIT
  773. K971494VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
  774. K053441BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
  775. K072876PRONTOSAN WOUND IRRIGATION SOLUTION
  776. K772413PINCH GUAGE
  777. K911435CPA/3.5 MHZ PROBE
  778. K151196Nautilus Spinal System
  779. K800742LIBERATOR/STROLLER II SYSTEM
  780. K153701ULYSS Multi View Sinuscope
  781. K960738STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)
  782. K193448BioNourish Lubricant
  783. K935851BIOMERIEUX HEMOLAB COFAC X
  784. K162627EnsoSleep
  785. K930952PRIDE LEGEND SC-340
  786. K940378COVERLET ADHESIVE DRESSING
  787. K040790MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS
  788. K153069Edwards Balloon Catheter
  789. K840515ACID FAST BACILLI STAIN CONTROL
  790. K994173STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY…
  791. K060917KENSEY NASH BONE VOID FILLER
  792. K924177CONFORT
  793. K031335POWDER FREE LATEX EXAM GLOVES
  794. K980714BCI 3401 HANDHELD PULSE OXIMETER
  795. K860325PRISTINE CULTURE CATHETER
  796. K946298BIOSTIM-HV
  797. K033001APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4
  798. K160803Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
  799. K051642FR.O.H. CALCANEUS REPAIR SYSTEM
  800. K896256REFLUX BED
  801. K97380023:1 REDUCTION ANGLE
  802. K110207ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
  803. K022031NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
  804. K782057CATHETER, RADIOPAQUE TENCKHOFF
  805. K991234THE ACME MEDICAL AESTHETIC ND:YAG LASER
  806. K253452Accuro 3S
  807. K013539ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
  808. K200215ADVIA Centaur CEA Assay
  809. K961945TYMPANOSTOMY VENTILATION TUBE
  810. BK210556Blood Establishment Computer Software and Accessories
  811. K923011OSTEONICS UNIX UNICOMPARTMENTAL
  812. K844296TRACHEAL TUBE, REINFORCED, CUFFED
  813. K992562PASCO MIC AND MIC/ID PANELS, CEFTRIAXONE
  814. K182629Digital Thermometer
  815. K061864DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560
  816. K830636POTASSIUM DILUENT
  817. K221717Disposable Surgical Gown UM-148
  818. K945860SPECTRUM CO-OXIMETER LINEARITY CONTROL
  819. K984030VIPERSOFT
  820. K842360DORR HIP PROSTHESIS FEMORAL COMPONENT
  821. K142676Siemens 3.0T PROCURE Array Coil
  822. K083783VF LIQUIGEL
  823. K920797HEMODIALYSIS BLOOD TUBING SET
  824. K021036INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000
  825. K945480MOSS(R) STEEL BREAKAWAY(R) INTRODUCER
  826. K030441SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
  827. K844425BEHIND THE EAR HEARING AIDS BERNAFON X-13
  828. K790462MEDTRONIC MODEL 6972
  829. K101575APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810…
  830. K101471AXLE INTERSPINOUS FUSION SYSTEM
  831. K100517INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
  832. K955069PLAYSKOOL
  833. K854298IRON
  834. K070028CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BASAL, LIGHTWEIGHT-PROBE…
  835. K141794ENDO-MARYLAND DISSECTOR
  836. K870941PHARMASEAL WOUND CARE DRESSING PAD
  837. K203419Relivion
  838. K210356Noris Medical Dental Implants System
  839. K870086ALANINE AMINOTRANSFERASE (ALT)/(GPT)
  840. K823686REAMER TYPE K ENDODONTIC
  841. K161480R2 Dermal Cooling System
  842. K073342SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW
  843. K903763COMPUTED TOMOGRAPHY X-RAY SYSTEM
  844. K902044MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM
  845. K083701PANASIL INITIAL CONTACT AND PANASIL TRAY
  846. K070319GC FUJI IX GP EXTRA
  847. K943257TIP DEFLECTOR (GENESIS)
  848. K860293CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS
  849. K802768FIBER OPTIC ADAPTER #60-0897
  850. K951085PADGETT AIR DERMATOME, MODEL A
  851. K182880Halifax Imaging Kit
  852. K091280FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT
  853. K991577NIC TONE ACRYLIC RESINS
  854. K945798MRT-35A UPGRADE 8.0CD
  855. K851866DAHLBERG MODEL DB BEHIND-THE-EAR HEARING AID
  856. K944537SCIMED TRIGUIDE GUIDE CATHETER
  857. K940372SUNGLASSES, SPECTACLE FRAMES
  858. K150376Sonoma Cancellous Bone Screw and Washer
  859. K861269RAICHEM AMYLASE REAGENT
  860. K261474DENTCA Tru Flexible
  861. K043129PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A)…
  862. K021822R120 MODULAR TOTAL HIP SYSTEM
  863. K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…
  864. K882315VIR-A-VAC EMPTY
  865. K891636PATIENT EXAMINATION GLOVES (LATEX)
  866. K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
  867. K181886VivaSight-DL System
  868. K211289RMU-2000 Automated Chest Compression System
  869. K870854BACTO(R) STREP GROUP KIT
  870. K122482TRANSTEK WRIST BLOOD PRESSURE MONITOR
  871. K870726RT5000 ECHOCARDIOGRAPHY #H4100C/CE
  872. K893334PREPOWDERED VINYL EXAM GLOVES
  873. K852388MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT
  874. K083095SONIXTOUCH ULTRASOUND SYSTEM
  875. K820469WARM & FORM KNEE SUPPORTS
  876. K895348MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT
  877. K802704SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR.
  878. K241135RESPOND(R) Ventilator
  879. K823097NATURELLE
  880. K133687THD N-ANO ANOSCOPE
  881. K040563LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25…
  882. K003791CAVEX TEMPORARY CEMENT
  883. K831914STRUNG NEURO SPONGE PATTIES-X-RAY-
  884. K011578M2376A DEVICELINK SYSTEM, MODEL M2376A
  885. K923385BOSTON BRAND HYPOALLERGENIC LATEX GLOVES
  886. K850604PRECO PREGNANCY RAPID CARD TEST, HEM #2028
  887. K791621MANNITOL SALT AGAR
  888. K863423CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100
  889. K972551ARTISAN PULSE LAVAGE SYSTEM
  890. K100213LUMANOSITY CELEBRITY, MODEL 204
  891. K140689IKNEE DISTAL FEMORAL CUTTING GUIDE
  892. K870739ABBOTT TESTPACK HCG COMBO
  893. K955867RESOUND PERSONAL HEARING SYSTEM BT247
  894. K831622MORHEL CLOSED URINARY DRAINAGE SET
  895. K061940SYNTHES LCP ANKLE ARTHRODESIS PLATES
  896. K951545OGDEN ANCHOR FOR ALL ORTHOPAEDIC SOFT TISSUE APPLICATIONS
  897. K1527138MP Color LCD Monitor, RadiForce RX850, RX850-AR
  898. K120979CAREFUSION NICOLET EDX
  899. K210388Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color
  900. K241913da Vinci Handheld Camera
  901. K032089ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
  902. K033546NUVASIVE SPINAL SYSTEM
  903. K120881MANTARAY GUIDEWIRES
  904. K033849SIMPLANT SYSTEM
  905. K210109visor2 system
  906. K001091CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
  907. K003639VITREA 2 CT PERFUSION OPTION
  908. K932904WINDMERE WAND MASSAGER
  909. K770991SERUM GLUTAMIC PYRUVIC TRANSAMINASE
  910. K200117Trevo NXT ProVue Retriever
  911. K862553ECG MODULE
  912. K914437CORRECT-S.I.M.
  913. K972944MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE…
  914. K903395UROMAT 2000
  915. K813495ALT (SGPT)
  916. K924577MEDIVAC
  917. K100363ULTRA DCI MODEL 5000
  918. K913022CCI VIDEOKERATOSCOPE/COMPARATOR
  919. K821311ESPREE' BREATHING CIRCUIT (W/ACCESS
  920. K790947AUTO ENZYMATIC CHOLESTEROL
  921. K082782REPLICATION MEDICAL VESSEL GUARD
  922. K871549RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]
  923. K842604EMERSON MOTION BED 6-MS & 6-ME
  924. K993151RADID DRUG SCREEN 5-PANEL TEST
  925. K101955ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL…
  926. K073058RESCUE INTERNAL IMPLANT SYSTEM
  927. K943614A.W.E.L.
  928. K830871PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION
  929. K1401083MP COLOR LCD DISPLAY
  930. K991765SYNERGY SHOULDER COIL
  931. K930987CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)
  932. K171901uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
  933. K946238SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPS
  934. K771125POLYURETHANE PROD. FOR I.V. NEEDLES
  935. K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™…
  936. K891252UROLOGICAL LOOP RETRIEVERS
  937. K915219URETHRAL ELECTRODE SHEATH
  938. K021561DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT…
  939. K893263LATEX EXAMINATION GLOVES
  940. K152171Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4
  941. K952422ELASTIC IMPRESSION CREAM
  942. K922797AESCULAP TROCAR INSTRUMENT SET
  943. K844073SEERAM BLADE
  944. K811416MOORE HIP PROSTHESIS, PMMA COATED
  945. K900220TRANS-PACE 100
  946. K020445THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
  947. K121890GENESYS PRESSFT SUTURE ANCHOR
  948. K801988NORDICLAB PROSTATIC ACID PHOSPHATASE RIA
  949. K883081RADKOR, XG-515
  950. K082883EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
  951. K003192MAGNETIC CONCERTO
  952. K024018AVANT GUARDIAN 101
  953. K213418MONTAGE Settable, Resorbable Hemostatic Bone Putty
  954. K920769KONICA LI 10 AND 10A LASER IMAGER
  955. K020723DIMENSION ALDL CALIBRATOR, MODEL DC131
  956. K100624INVENDO C20 COLONOSCOPY SYSTEM
  957. K873716ADULT WALKING HEEL PRODUCT NO. 4183-130
  958. K935101URINE CALIBRATORS AND CONTROLS MODIFICATION
  959. K790331ZIMMER SURGICAL INSTRUMENT LUBRICANT
  960. K190224Medline Burn and Wound Dressing (OTC)
  961. K772331RESTERIL. OF IMPLANT. ELECT. & ADAPTER
  962. K221241DrAid for Radiology v1
  963. K040727CRYO 5
  964. K971709TOTAL THROXINE MICROPLATE EIA(225-300)
  965. K8527917 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS
  966. K020463DEPILASE YAG LASE PLUS LASER SYSTEM
  967. K863497SUCTION CATHETER KIT
  968. K132461A.I.M. SUTURE ANCHOR
  969. K982320DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
  970. K862476LS3000 CANNULA UTERINE SUCTION
  971. K941196PLATEX TAMPONS MODEL NUMBER 07094
  972. K935404FLOW DIRECTED THERMODILUTION BALLOON CATHETER
  973. K914406PT II DISTAL CEMENT SPACER
  974. K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
  975. K873551CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95
  976. K171985Astroglide O Oil Personal Lubricant & Massage Oil
  977. K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
  978. K013415SYNTHES ANKLE ARTHRODESIS PLATE
  979. K924941CONCEPT 4MM CANCELLOUS SCREW WITH EYELET
  980. K071894XEBRA DICOM IMAGE BROWSER
  981. K924511MONOJECT(R) 6 CC SAFETY SYRINGE
  982. K130770MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
  983. K812949RMI TRANSILLUMINATOR, MODEL 292
  984. K261086Break Wave
  985. K862127DYMAX PERSONAL SCANNER
  986. K923313ROCHE OXI/FERM II
  987. K093544TROPAZONE CR
  988. K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…
  989. K861025T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES
  990. K932403AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN
  991. K023305KEGELMASTER 2000
  992. K240543Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)
  993. K251892MAXXOS P.A.C.E. Foot & Ankle Plating System
  994. K820416#505 PORT. VITAL FUNCTIONS NEONATAL MON
  995. K010751BPFONE, MODEL UA 767IT
  996. K223669SecurePortIV Advanced Catheter Securement Adhesive
  997. K090960VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104…
  998. K811021HERPES
  999. K861608UNICARE BREAST SHELLS
  1000. K243230Second Opinion® BLE

About this dataset

A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Source: U.S. Food and Drug Administration (FDA), 510(k) Premarket Notification database