Data catalog

PMA approvals

About 1,529 records

More records

Continuing the PMA approvals list, 1000 records per page, after P810001.

  1. P810002BILEAFLET-CENTER OPENING CARDIAC VALVE
  2. P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS
  3. P810006COLLASTAT
  4. P810007JAUNDICE METER 101
  5. P810018POSTERIOR CHAMBER INTRAOCULAR LENSES
  6. P810020PALACOS R BONE CEMENT
  7. P810023COBE CENTRY(R) TPE SYSTEM
  8. P810024AUTOBAC MTS PLUS TEST SYTEM
  9. P810025AMVISC(R)
  10. P810031HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
  11. P810032MODELS B-13F (P-10) & B-1H (P-11)
  12. P810033SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355
  13. P810040SUPERSTAT
  14. P810042MODELS 011 & 011B IRIDOCAPSULAR IOLS
  15. P810044DIABETES SENTRY
  16. P810046SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
  17. P810048OSTEO CERAMIC HIP
  18. P810055MODELS 019B, 019C, 019E, 019F, 019J, & 019K
  19. P810056MODEL AC10 & AC20 IOLS
  20. P820002CRYOMAX(TM)
  21. P820003VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR
  22. P820008SCOLITRON(TM) STIMULATOR
  23. P820009LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER
  24. P820012COSMAN ICP TELE-SENSOR(R)
  25. P820018AUTIMA(TM) MODEL 2251 & MODEL 2600
  26. P820021SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS
  27. P820022CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER
  28. P820023PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P
  29. P820027SOFTMARK
  30. P820032PLASMA SEPARATION SYSTEM
  31. P820033PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR
  32. P820034REPRO-MED - THD
  33. P820035OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5)
  34. P820044MODEL 91-50 IOL
  35. P820049MODELS PC10 & PC21
  36. P820052RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
  37. P820060ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER
  38. P820072CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC
  39. P820073MICUR-MIC SYSTEMS
  40. P820075LAMICEL(TM)
  41. P820076DIPLOS MODEL 05 A & B
  42. P820077AFP MID-PREGNANCY REFERENCE PREPARATION
  43. P820078AL-47 SOFT CONTACT LENS
  44. P820079CDS II (SODIUM CHONDROITIN SULFATE)
  45. P820086CIBATINT(TM) TINTING PROCESS
  46. P820088BSD 1000 HYPERTHERMIA SYSTEM
  47. P830007GEMINI(R) THETA MODEL 415A CARDIAC PACER
  48. P830010CURESIS PLASMA SEPARATOR
  49. P830018HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM
  50. P830025MEDITEC OPL3 ND:YAG LASER
  51. P830026COSMOS(TM) SYSTEM
  52. P830028UNISCEPT(TM)
  53. P830033STYLE 17 & 17A POSTERIOR CHAMBER IOLS
  54. P830035GK-101E CARIES REMOVAL AGENT/SYSTEM
  55. P830037DURASOFT(R) 3 FOR EXT WEAR
  56. P830039OMNISCEINCE PROSTHETIC CARDIAC VALVE
  57. P830040STYLES 30 & 31 POSTERIOR CHAMBER IOLS
  58. P830045MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S
  59. P830047X-70 SOFT CONTACT LENS
  60. P830054NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900
  61. P830055LCS(R) TOTAL KNEE SYSTEM
  62. P830056STYLES 31-34 POSTERIOR IOLS
  63. P830060VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS
  64. P830061STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING
  65. P830062ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
  66. P830063GAMBRO FIBER PLASMAFILTER
  67. P8300693M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN
  68. P830070AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
  69. P830079INSTAT(TM) COLLAGEN ABSORBABLE HEMOSTAT
  70. P830080PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER
  71. P840001ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS
  72. P840002STAT-PACE II
  73. P840008DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT)
  74. P840012MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
  75. P840014DDD PULSE GENERATOR 674
  76. P840015CLINI-THERM MARK I/IV
  77. P840024NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI
  78. P840027CEA-ROCHE(R) EIA
  79. P840029MICROVEL(R) WITH HEMASHIELD
  80. P840031SAULFON PW-70 A&B
  81. P840039ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES
  82. P840040MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS
  83. P840044TORAY SOFT CONTACT LENSES
  84. P840045DILAPAN-S CERVICAL DILATOR
  85. P840047CILCO ND:YAG LASER
  86. P840049P.C.A.(TM) TOTAL KNEE SYSTEM
  87. P840050OCUSIL(TM) CONTACT LENS
  88. P840060SM-1, CR-1, & GR-1 IOLS
  89. P840062COLLACOTE(TM)
  90. P840064VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
  91. P840065COBAS BACT
  92. P840068DELTA PACEMAKER SYS; VIGOR DDD MODEL 950
  93. P840070HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
  94. P850006DUROMEDICS BILEAFLET HEART VALVE
  95. P850007PHYSIO-STIM(TM) I & II MODEL 6000 & 7000
  96. P850010HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
  97. P850019PHOTOTOME(TM) SYSTEM 2700
  98. P850020PROSORBA(TM) COLUMN
  99. P850021AMER, ED. LABS. PTCA
  100. P850022Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak®…
  101. P850023HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT
  102. P850027TELECTRONICS PASAR MODEL 4171 PG
  103. P850029ABBOTT ER-EIA MONOCLONAL DIAG. KIT
  104. P850033SCANLENS (SCAFILCON A CONTACT LENS)
  105. P850035SpF® Implantable Spinal Fusion Stimulator
  106. P850038PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN
  107. P850039B&L 58(TM) (ETAFILCONA) CONTACT LENS
  108. P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
  109. P850049COOK BIRD'S NEST VENA CAVA FILTER
  110. P850051ACTIVITRAX MODELS 8400, 8402, 8403
  111. P850053FIBREL
  112. P850054STRKYER KNEE AUGMENTATION GRAFT
  113. P850057CUSTOMEYES(TM) 45L&55L (BUFILCON A)
  114. P850058CUSTOMEYES 70L & 79L (LIDOFILCON A&B)
  115. P850059KELMAN(TM) OMNIFIT II MODEL 2100
  116. P850062ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)
  117. P850063MICRO YAG ND:YAG LASER SYSTEM
  118. P850064MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR
  119. P850068SILSOFT (ELASTOFILCON A) CONTACT LENSES
  120. P850069KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE
  121. P850072DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
  122. P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS
  123. P850078KONTUR 55 EW
  124. P850079HYDRASOFT (METHAFILCON B) CONTACT LENS
  125. P850089CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS…
  126. P850091YAGMASTER ND:YAG OP LASER
  127. P850092THERAPEUTIC APHERESIS SYSTEM
  128. P860002INTRAOCULAR LENS
  129. P860003UVAR PHOTOPHERESIS SYSTEM
  130. P860004MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM
  131. P860005PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER
  132. P860007INTERTACH TM IMPLANTABLE PACEMAKER PULSE
  133. P860008ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7
  134. P860012ALVEOFORM TM BIOGRAFT
  135. P860015FLUORO-CEP{R} ESTROGEN ASSAY REAGENT
  136. P860019SCIMED PTCA DILATATION CATHETER
  137. P860022BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT…
  138. P860026DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
  139. P860027MAESTRO SERIES 500 P.G. MODELS 501, 505, 509
  140. P860034MODEL AC-21 OMNIFIT ANTERIOR CHAMBER
  141. P860035TITRATOR MODEL 10K
  142. P860040SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES
  143. P860042TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
  144. P860046THERAPEUTIC ULTRASOUND FOR TREATMENT OF GLAUCOMA
  145. P860047HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML
  146. P860057EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES
  147. P860059MODEL 304 (ULTRA C-LOOP)
  148. P860064DAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR…
  149. P860067SALITRON SYSTEM
  150. P870011HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE
  151. P870013IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR
  152. P870015MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT
  153. P870018LITHOSTAR
  154. P870021PRIME{TM} MODEL 6520, 6525, 6530 AND 6535
  155. P870024FLUOROPERM RGP CONTACT LENSES
  156. P870025FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY
  157. P870036VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM
  158. P870038STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES
  159. P870043SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER
  160. P870045SK15 AND SK16
  161. P870048EBK
  162. P870049MICROSCAN RAPID PANELS
  163. P870054KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR
  164. P870056CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625
  165. P870059PERIOCHECK TM ENZYME ACTIVITY TEST KIT
  166. P870062PRENTIF TM CAVITY RIM CERVICAL CAP
  167. P870069BIOBRANE(R) II
  168. P870072THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
  169. P870073STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES
  170. P870076FALOPE RING BAND AND APPLICATOR SYSTEMS
  171. P870077CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
  172. P870078HANCOCK PORCINE BIOPROSTHESIS
  173. P870080HULKA CLIP FOR TUBAL OCCLUSION
  174. P880003CORDIS PTCA DILATATION CATHETER
  175. P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM
  176. P880009VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT
  177. P880010INTRAOCULAR LENS MODELS C118;C119;C138 AND C139
  178. P880011TECHNOMED INTERNATIONAL SONOLITH 2000
  179. P880013INFANT STAR HIGH FREQUENCY VENTILATOR
  180. P880016ONCOR B/T GENE REARRANGEMENT TEST
  181. P880026ABBOTT ER-ICA MONOCLONAL
  182. P880027MICROSOFTRAC TM (PTCA) CATHETER
  183. P880028DEXTRAN HM 32%
  184. P880029B AND L 70 LIDOFILCON A CONTACT LENSE
  185. P880031VITRAX SODIUM HYALURONATE
  186. P880032BIO-RAD CYCLOSPORINE BY HPLC TEST
  187. P880038META-MV,PACING SYSTEM
  188. P880040CELLFREE INTERLEUKIN-2RECEPTOR ASSAY KIT
  189. P880042EDAP LT.01 SHOCK WAVE LITHOTRIPTER
  190. P880045OSI TRANSPROBE-1
  191. P880047INTERCEED TC7 ABSORBABLE ADHESION BARRIER
  192. P880055CORONARY BALLOON DILATATION CATHETER
  193. P880062SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
  194. P880064HYPERTHERMIA SYSTEM 100 A
  195. P880065MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
  196. P880070MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS
  197. P880072MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL
  198. P880078VH8500 HYPERTHERMIA TREATMENT SYSTEM
  199. P880081UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
  200. P880082MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES
  201. P880085MODEL 405 SPANFLEX TM IOL
  202. P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS
  203. P880087KELMAN MULTIFLEX 2 MODELS: MT3-MT7 & MT2U-MT7U
  204. P880089AGENASORB
  205. P880090MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS
  206. P880091ELASTIC UVA PC IOL.
  207. P880094DACRON SURGICAL SUTURES
  208. P880098MENICON SF-P RGP (MELAFOCON A) CONTACT LENS
  209. P890001LEOCOR,INC. MODELS 1
  210. P890002POLYPROPYLENE SURGICAL SUTURE
  211. P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071
  212. P890012SIGNATURE CONTACT LENS
  213. P890013RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300
  214. P890014HA-IGMK AND ETI-HA-IGMK
  215. P890017PALMAZ BALLOON EXPANDABLE STENT
  216. P890019AB -HAVK
  217. P890020FLUOROCON TM-60
  218. P890023H55 HYDROPHILIC CONTACT LENS
  219. P890024TROPHOCAN TM
  220. P890025TD CYCLOSPORINE AND METABOLITES SERUM ASSAY
  221. P890027NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDREN
  222. P890029EXCELENS (ATLAFILCON A) CONTACT LENS
  223. P890032CORDIS STEERABLE PTCA BALLOON CATHETER
  224. P890034MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR
  225. P890039MASTRO SAVVI SERIES 300 VDD PACING SYSTEM
  226. P890040SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS
  227. P890043SIMPSON CORONARY ATHEROCATH(TM)
  228. P890045GELSEAL TM TRIAXIAL VASCULAR GRAFT
  229. P890047PROVISC(TM)VISCOELASTIC PREPARATION
  230. P890048USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM
  231. P890049FINISHED METHAFILCON A CONTACT LENSES
  232. P890055MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM
  233. P890056MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS
  234. P890057MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR
  235. P890061VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE
  236. P890063GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
  237. P890064VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT
  238. P890065CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS
  239. P890066THERASONIC LITHOTRIPSY TREATMENT SYSTEM
  240. P890068MODEL P-11 MODIFIED J-LOOP POSTERIOR CHAMBER IOL
  241. P890070PURE-DENT (R)
  242. P900007COOK CHORIONIC VILLUS SAMPLING SET
  243. P900009SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
  244. P900013ABBOTT PGR-EIA MONOCLONAL
  245. P900016MIRA-FLO STARCH
  246. P900022CHORUS DDD PACEMAKER
  247. P900023ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM
  248. P900025FLUORO-CEP (R) PROGESTERONE
  249. P900030CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT
  250. P900032AIS EXIMER LASER ANGIOPLASTY
  251. P900033INTEGRA DERMAL REGENERATION TEMPLATE
  252. P900037MODIFIED J&C LOOP POST. CHAMBER INTRAOCULAR LENS
  253. P900038PARASTEP-I
  254. P900039COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE
  255. P900042AWARE TEST SYSTEM
  256. P900043PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT
  257. P900048ELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM
  258. P900050ACCESS MOBILITY SYSTEM
  259. P900052PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEM
  260. P900053MODELS A21-A & A21-B POSTERIOR CHAMBER INTRAOCULAR
  261. P900056ROTABLATOR(R)
  262. P900060CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
  263. P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM
  264. P900066PERFLUOROPROPANE
  265. P900067SULFUR HEXAFLUORIDE
  266. P900070META DDDR PACING SYSTEM
  267. P910001SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
  268. P910007AXSYM TOTAL PSA & ARCHITECT TOTAL PSA
  269. P910016NEW JERSEY LCS(R) TOTAL KNEE SYSTEM
  270. P910018LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB…
  271. P910019IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
  272. P910020RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS
  273. P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM
  274. P910030GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)
  275. P910031ORACLE(TM) CORONARY BALLOON DILATATION CATHETER
  276. P910054INOUE BALLOON CATHETER
  277. P910056SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS
  278. P910058CHIROFLEX MODELS 32 C10XX SILICONE POSTERIOR IOL
  279. P910061MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS
  280. P910062VISX MODELB/MODEL C EXCIMER LASER SYSTEM
  281. P910063CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM
  282. P910064F C FEMALE CONDOM
  283. P910065AIA-PACK PSA
  284. P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
  285. P910067EXCIMED(TM) UV200LA LASER SYSTEM
  286. P910068VITREON(R)
  287. P910071ADATOMED SILICONE OIL OP5000
  288. P910073ENDOTAK LEAD SYSTEM
  289. P910077VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR
  290. P920004VASOSEAL (TM)
  291. P920006IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE
  292. P920011MAXIM PFS MODEL 033-301
  293. P920014HEARTMATE VE LVAS
  294. P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEM
  295. P920023UROLUME ENDOPROSTHESIS
  296. P920027ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II
  297. P920030CIBA CORNING ACS PSA IMMUNOASSAY
  298. P920031EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
  299. P920032MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
  300. P920034TRIPTER-X1 NOVA
  301. P920038SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM
  302. P920046FILSHIE CLIP (MARK VI) SYSTEM
  303. P920047EPT-1000 CARDIAC ABLATION SYSTEM
  304. P920048FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)
  305. P920051STORZ MODULITH (TM) LITHOTRIPTER
  306. P930014ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES
  307. P930016VISX EXCIMER LASER SYSTEM MODELS B AND C
  308. P930021BIORA EMDOGAIN(R)
  309. P930022MEDTRONIC(R) LEGEND PLUS(TM) PULSE GENERATOR
  310. P930024GRIESHABER SCLERAL BUCKLING BALLOON CATHETER
  311. P930027IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS
  312. P930029ATAKR(TM) RFCA SYSTEM
  313. P930030HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE
  314. P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
  315. P930034SVS APEX EXCIMER LASER SYSTEM
  316. P930035VENTAK(R) P2 SYSTEM
  317. P930036ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS
  318. P930038Angio Seal Vascular Closure Device
  319. P930039MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
  320. P940001GENESA(R) SYSTEM
  321. P940002NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)
  322. P940004ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI
  323. P940005ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM
  324. P940007PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL
  325. P940008RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL)…
  326. P940009PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH
  327. P940010OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
  328. P940011COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
  329. P940012600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG…
  330. P940013PRECISION(TM) UV (VASURFILCON)
  331. P940015SYNVISC ONE
  332. P940016H.E.L.P. SYSTEM
  333. P940019WALLSTENT(R) ILIAC ENDOPROSTHESIS
  334. P940022CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT
  335. P940024GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
  336. P940029PAPNET (R) TESTING SYSTEM
  337. P940031VIGOR(TM) DR PACEMAKER SYSTEM
  338. P940033FEMIDOM
  339. P940034GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
  340. P940035NMP22 BladderChek Test
  341. P940036BARTELS CHEMORESPONSE ASSAY
  342. P940040AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST
  343. P950001SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
  344. P950002BAK INTERBODY FUSION SYSTEM
  345. P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER
  346. P950008SILIKON 1000
  347. P950009AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
  348. P950011TRUQUANT(R) BR(TM) RIA
  349. P950014PROSTATRON
  350. P950015THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION
  351. P950018PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)
  352. P950019RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION
  353. P950020FLEXATOME CUTTING BALLOON
  354. P950021ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY
  355. P950022TVL(TM) LEAD SYSTEM
  356. P950024MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
  357. P950027HYALGAN(R)
  358. P950029CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER
  359. P950032APLIGRAF (GRAFTSKIN)
  360. P950034SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
  361. P950035NEUROCONTROL FREEHAND SYSTEM(R)
  362. P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
  363. P950039THINPREP(R) PROCESSOR, MODEL TP 2000
  364. P950040DR. BROWN'S HOME DRUG TESTING KIT
  365. P950042PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
  366. P950043ECONOLITH(TM) LITHOTRIPTER
  367. P960001DEPUY 1 BONE CEMENT
  368. P960004THINLINE ENDOCARDIAL PACING LEADS
  369. P960006SWEET TIP(R) RX STEROID ELUTING LEAD
  370. P960007TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
  371. P960009MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
  372. P960010MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM
  373. P960011BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
  374. P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
  375. P960014MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL…
  376. P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEM
  377. P960018THE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2
  378. P960019LASERVISION/VISX EXCIMER LASER MODEL C
  379. P960020RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE
  380. P960022SOFLENS66(TM)
  381. P960025BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS
  382. P960028AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
  383. P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
  384. P960031PERIOGARD PERIODONTAL TISSUE MONITOR
  385. P960033STAARVISC TM SODIUM HYALURONATE
  386. P960034CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT.
  387. P960036MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL…
  388. P960039SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
  389. P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE…
  390. P960042SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
  391. P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
  392. P960044NEEDLE-EASE TM 2501
  393. P960047OSTEONICS CONSTRAINED ACETABULAR INSERT
  394. P960052DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)
  395. P960053BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
  396. P960054S-ROM POLY-DIAL CONSTRAINED LINER
  397. P960057ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
  398. P960058CLARION MULTI-STRATEGY COCHLEAR IMPLANT
  399. P970002MONOSTRUT CARDIAC VALVE PROSTHESIS
  400. P970003VNS THERAPY SYSTEM
  401. P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL
  402. P970005KREMER LASER SYSTEM
  403. P970007IMX TACROLIMUS II ASSAY
  404. P970008TARGIS (T3) SYSTEM
  405. P970010NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT
  406. P970012MEDTRONIC.KAPPA 400 SERIES PACEMAKERS
  407. P970013MICRONY PACEMAKERS
  408. P970015INTER FIX THREADED FUSION DEVICE
  409. P970017SAHARA CLINICAL BONE SONOMETER
  410. P970018BD PREPSTAIN SYSTEM
  411. P970019HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
  412. P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS
  413. P970021THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
  414. P970024ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM…
  415. P970025PRO-TRAC II TACROLIMUS ELISA KIT
  416. P970026MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN
  417. P970027ABBOTT AXSYM ANTIBODY TO HCV
  418. P970029TMR HOLMIUM LASER SYSTEM
  419. P970030TORONTO SPV VALVE
  420. P970031MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
  421. P970032SALEST TM SYSTEM
  422. P970033T-SCAN 2000
  423. P970034MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
  424. P970035AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY…
  425. P970036NIC 1800 NEEDLE DISPOSAL SYSTEM
  426. P970037AUTODELFIA HAFP TEST KIT
  427. P970038TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
  428. P970040ACHILLES EXPRESS ULTRASONOMETER
  429. P970042MEDSTONE STS LITHOTRIPTER
  430. P970043LADARVISION EXCIMER LASER SYSTEM
  431. P970044DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
  432. P970049DISHLER EXCIMER LASER SYSTEMS
  433. P970051NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
  434. P970052FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS
  435. P970053EC-5000 EXCIMER LASER SYSTEM
  436. P970054BIOTRIN PARVOVIRUS B19 IGG
  437. P970055BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)
  438. P970056BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
  439. P970058M1000 IMAGECHECKER
  440. P970061SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM
  441. P970062GENESTONE 190 LITHOTRIPTER
  442. P980001NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM
  443. P980003CHILLI COOLED RF ABLATION SYSTEM
  444. P980006PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR
  445. P980007AXSYM FREE PSA
  446. P980008LASERSCAN LSX EXCIMER LASER SYSTEM
  447. P980009MAGIC WALLSTENT ENDOPROTHESIS
  448. P980010DTU-ONE ULTRASOUND SCANNER
  449. P980012NOVACOR LVAS
  450. P980015SHARPX
  451. P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS
  452. P980017PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20
  453. P980018DAKO HERCEPTEST
  454. P980020Q 103 NEEDLE MANAGEMENT SYSTEM
  455. P980022CONTINUOUS GLUCOSE MONITORING SYSTEM
  456. P980023PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
  457. P980024PATHVYSION HER-2 DNA PROBE KIT
  458. P980025LOGICON CARIES DETECTOR
  459. P980031INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
  460. P980033WALLSTENT ENDOPROSTHESIS
  461. P980035MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE
  462. P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER
  463. P980040SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
  464. P980041ACCESS AFP IMMUNOASSAY SYSTEM
  465. P980043HANCOCK II PORCINE BIOPROSTHESIS
  466. P980044SUPARTZ FX
  467. P980046HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
  468. P980048BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM
  469. P980049DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
  470. P980050MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL…
  471. P980052TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
  472. P980053DURASPHERE INJECTABLE BULKING AGENT
  473. P990001DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2
  474. P990002FEMSOFT URETHRAL INSERT
  475. P990004SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
  476. P990008COOK MBC PTCA BALLOON DILATATION CATHETER
  477. P990009FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT
  478. P990010VISX EXCIMER LASER SYSTEM MODEL C STAR
  479. P990012ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
  480. P990013COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
  481. P990014HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
  482. P990015INTERGEL ADHESION PREVENTION SOLUTION
  483. P990016MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0
  484. P990017ANCURE(TM) TUBE SYSTEM, ANCURE(TM) BIFURCATED SYSTEM
  485. P990018MENICON Z RIGID GAS PERMEABLE CONTACT LENS
  486. P990019BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
  487. P990020ANEURX STENT GRAFT SYSTEM
  488. P990021DIOMED 630 PDT LASER
  489. P990023CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
  490. P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
  491. P990026GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
  492. P990027TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
  493. P990028FOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT
  494. P990030VITAGEL SURGICAL HEMOSTAT
  495. P990033PEPGEN P-15
  496. P990034MEDTRONIC ISOMED INFUSION SYSTEM
  497. P990035THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER
  498. P990036CORDIS CHECKMATE(TM) SYSTEM
  499. P990037VASCULAR SOLUTIONS DUETT SEALING DEVICE
  500. P990038DIASORIN ETI MAK-2 PLUS ASSAY
  501. P990039QUS-2 (TM) CALCANEAL ULTRASONOMETER
  502. P990040TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
  503. P990041DIASORIN ETI-AB-EBK PLUS ASSAY
  504. P990042DIASORIN ETI-AB-AUK PLUS ASSAY
  505. P990043DIASORIN ETI-EBK PLUS ASSAY
  506. P990044DIASORIN ETI-CORE-IGMK PLUS ASSAY
  507. P990045DIASORIN ETI-AB-COREK PLUS ASSAY
  508. P990046ATS OPEN PIVOT BILEAFLET HEART VALVE
  509. P990048ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER
  510. P990049COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM
  511. P990050OPTICAL BIOPSY(TM) SYSTEM
  512. P990052VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM
  513. P990053OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
  514. P990054CHILLI COOLED ABLATION SYSTEM
  515. P990055BAYER IMMUNO 1 COMPLEXED PSA ASSAY
  516. P990056ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
  517. P990064MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
  518. P990065SIR-SPHERES
  519. P990066GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
  520. P990069ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE…
  521. P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
  522. P990072W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES
  523. P990074NATRELLE SALINE BREAST IMPLANTS
  524. P990075MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
  525. P990078HYPERION LTK SYSTEM
  526. P990080CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL…
  527. P990081PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
  528. P990085VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH…
  529. P990086HEALTHTRONICS OSSATRON

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