Data catalog
PMA approvals
About 1,529 records
More records
Continuing the PMA approvals list, 1000 records per page, after P810001.
- P810002BILEAFLET-CENTER OPENING CARDIAC VALVE
- P810005WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS
- P810006COLLASTAT
- P810007JAUNDICE METER 101
- P810018POSTERIOR CHAMBER INTRAOCULAR LENSES
- P810020PALACOS R BONE CEMENT
- P810023COBE CENTRY(R) TPE SYSTEM
- P810024AUTOBAC MTS PLUS TEST SYTEM
- P810025AMVISC(R)
- P810031HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
- P810032MODELS B-13F (P-10) & B-1H (P-11)
- P810033SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355
- P810040SUPERSTAT
- P810042MODELS 011 & 011B IRIDOCAPSULAR IOLS
- P810044DIABETES SENTRY
- P810046SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
- P810048OSTEO CERAMIC HIP
- P810055MODELS 019B, 019C, 019E, 019F, 019J, & 019K
- P810056MODEL AC10 & AC20 IOLS
- P820002CRYOMAX(TM)
- P820003VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR
- P820008SCOLITRON(TM) STIMULATOR
- P820009LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER
- P820012COSMAN ICP TELE-SENSOR(R)
- P820018AUTIMA(TM) MODEL 2251 & MODEL 2600
- P820021SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS
- P820022CYBERTACH(TM) 60 PULSE GENERATOR & PROGRAMMER
- P820023PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P
- P820027SOFTMARK
- P820032PLASMA SEPARATION SYSTEM
- P820033PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR
- P820034REPRO-MED - THD
- P820035OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5)
- P820044MODEL 91-50 IOL
- P820049MODELS PC10 & PC21
- P820052RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
- P820060ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER
- P820072CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC
- P820073MICUR-MIC SYSTEMS
- P820075LAMICEL(TM)
- P820076DIPLOS MODEL 05 A & B
- P820077AFP MID-PREGNANCY REFERENCE PREPARATION
- P820078AL-47 SOFT CONTACT LENS
- P820079CDS II (SODIUM CHONDROITIN SULFATE)
- P820086CIBATINT(TM) TINTING PROCESS
- P820088BSD 1000 HYPERTHERMIA SYSTEM
- P830007GEMINI(R) THETA MODEL 415A CARDIAC PACER
- P830010CURESIS PLASMA SEPARATOR
- P830018HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM
- P830025MEDITEC OPL3 ND:YAG LASER
- P830026COSMOS(TM) SYSTEM
- P830028UNISCEPT(TM)
- P830033STYLE 17 & 17A POSTERIOR CHAMBER IOLS
- P830035GK-101E CARIES REMOVAL AGENT/SYSTEM
- P830037DURASOFT(R) 3 FOR EXT WEAR
- P830039OMNISCEINCE PROSTHETIC CARDIAC VALVE
- P830040STYLES 30 & 31 POSTERIOR CHAMBER IOLS
- P830045MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S
- P830047X-70 SOFT CONTACT LENS
- P830054NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900
- P830055LCS(R) TOTAL KNEE SYSTEM
- P830056STYLES 31-34 POSTERIOR IOLS
- P830060VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS
- P830061STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING
- P830062ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
- P830063GAMBRO FIBER PLASMAFILTER
- P8300693M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN
- P830070AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
- P830079INSTAT(TM) COLLAGEN ABSORBABLE HEMOSTAT
- P830080PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER
- P840001ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS
- P840002STAT-PACE II
- P840008DORNIER LITHOTRIPTER COMPACT TRANSPORTABLE (DLCT)
- P840012MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
- P840014DDD PULSE GENERATOR 674
- P840015CLINI-THERM MARK I/IV
- P840024NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI
- P840027CEA-ROCHE(R) EIA
- P840029MICROVEL(R) WITH HEMASHIELD
- P840031SAULFON PW-70 A&B
- P840039ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES
- P840040MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS
- P840044TORAY SOFT CONTACT LENSES
- P840045DILAPAN-S CERVICAL DILATOR
- P840047CILCO ND:YAG LASER
- P840049P.C.A.(TM) TOTAL KNEE SYSTEM
- P840050OCUSIL(TM) CONTACT LENS
- P840060SM-1, CR-1, & GR-1 IOLS
- P840062COLLACOTE(TM)
- P840064VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES
- P840065COBAS BACT
- P840068DELTA PACEMAKER SYS; VIGOR DDD MODEL 950
- P840070HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST
- P850006DUROMEDICS BILEAFLET HEART VALVE
- P850007PHYSIO-STIM(TM) I & II MODEL 6000 & 7000
- P850010HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
- P850019PHOTOTOME(TM) SYSTEM 2700
- P850020PROSORBA(TM) COLUMN
- P850021AMER, ED. LABS. PTCA
- P850022Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak®…
- P850023HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT
- P850027TELECTRONICS PASAR MODEL 4171 PG
- P850029ABBOTT ER-EIA MONOCLONAL DIAG. KIT
- P850033SCANLENS (SCAFILCON A CONTACT LENS)
- P850035SpF® Implantable Spinal Fusion Stimulator
- P850038PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN
- P850039B&L 58(TM) (ETAFILCONA) CONTACT LENS
- P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAY
- P850049COOK BIRD'S NEST VENA CAVA FILTER
- P850051ACTIVITRAX MODELS 8400, 8402, 8403
- P850053FIBREL
- P850054STRKYER KNEE AUGMENTATION GRAFT
- P850057CUSTOMEYES(TM) 45L&55L (BUFILCON A)
- P850058CUSTOMEYES 70L & 79L (LIDOFILCON A&B)
- P850059KELMAN(TM) OMNIFIT II MODEL 2100
- P850062ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)
- P850063MICRO YAG ND:YAG LASER SYSTEM
- P850064MODEL 203 LIFE PULSE HIGH FREQUENCY VENTILATOR
- P850068SILSOFT (ELASTOFILCON A) CONTACT LENSES
- P850069KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE
- P850072DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
- P850077SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS
- P850078KONTUR 55 EW
- P850079HYDRASOFT (METHAFILCON B) CONTACT LENS
- P850089CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS…
- P850091YAGMASTER ND:YAG OP LASER
- P850092THERAPEUTIC APHERESIS SYSTEM
- P860002INTRAOCULAR LENS
- P860003UVAR PHOTOPHERESIS SYSTEM
- P860004MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM
- P860005PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER
- P860007INTERTACH TM IMPLANTABLE PACEMAKER PULSE
- P860008ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7
- P860012ALVEOFORM TM BIOGRAFT
- P860015FLUORO-CEP{R} ESTROGEN ASSAY REAGENT
- P860019SCIMED PTCA DILATATION CATHETER
- P860022BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT…
- P860026DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR
- P860027MAESTRO SERIES 500 P.G. MODELS 501, 505, 509
- P860034MODEL AC-21 OMNIFIT ANTERIOR CHAMBER
- P860035TITRATOR MODEL 10K
- P860040SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES
- P860042TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
- P860046THERAPEUTIC ULTRASOUND FOR TREATMENT OF GLAUCOMA
- P860047HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML
- P860057EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES
- P860059MODEL 304 (ULTRA C-LOOP)
- P860064DAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR…
- P860067SALITRON SYSTEM
- P870011HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE
- P870013IOLAB SUREFIT MODELS 85JS, 85JM & 85JL ANTERIOR
- P870015MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT
- P870018LITHOSTAR
- P870021PRIME{TM} MODEL 6520, 6525, 6530 AND 6535
- P870024FLUOROPERM RGP CONTACT LENSES
- P870025FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY
- P870036VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM
- P870038STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES
- P870043SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER
- P870045SK15 AND SK16
- P870048EBK
- P870049MICROSCAN RAPID PANELS
- P870054KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR
- P870056CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625
- P870059PERIOCHECK TM ENZYME ACTIVITY TEST KIT
- P870062PRENTIF TM CAVITY RIM CERVICAL CAP
- P870069BIOBRANE(R) II
- P870072THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
- P870073STORZ POSTERIOR CHAMBER INTRAOCULAR LENSES
- P870076FALOPE RING BAND AND APPLICATOR SYSTEMS
- P870077CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS
- P870078HANCOCK PORCINE BIOPROSTHESIS
- P870080HULKA CLIP FOR TUBAL OCCLUSION
- P880003CORDIS PTCA DILATATION CATHETER
- P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM
- P880009VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT
- P880010INTRAOCULAR LENS MODELS C118;C119;C138 AND C139
- P880011TECHNOMED INTERNATIONAL SONOLITH 2000
- P880013INFANT STAR HIGH FREQUENCY VENTILATOR
- P880016ONCOR B/T GENE REARRANGEMENT TEST
- P880026ABBOTT ER-ICA MONOCLONAL
- P880027MICROSOFTRAC TM (PTCA) CATHETER
- P880028DEXTRAN HM 32%
- P880029B AND L 70 LIDOFILCON A CONTACT LENSE
- P880031VITRAX SODIUM HYALURONATE
- P880032BIO-RAD CYCLOSPORINE BY HPLC TEST
- P880038META-MV,PACING SYSTEM
- P880040CELLFREE INTERLEUKIN-2RECEPTOR ASSAY KIT
- P880042EDAP LT.01 SHOCK WAVE LITHOTRIPTER
- P880045OSI TRANSPROBE-1
- P880047INTERCEED TC7 ABSORBABLE ADHESION BARRIER
- P880055CORONARY BALLOON DILATATION CATHETER
- P880062SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYSTEM
- P880064HYPERTHERMIA SYSTEM 100 A
- P880065MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
- P880070MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS
- P880072MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL
- P880078VH8500 HYPERTHERMIA TREATMENT SYSTEM
- P880081UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
- P880082MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES
- P880085MODEL 405 SPANFLEX TM IOL
- P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS
- P880087KELMAN MULTIFLEX 2 MODELS: MT3-MT7 & MT2U-MT7U
- P880089AGENASORB
- P880090MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS
- P880091ELASTIC UVA PC IOL.
- P880094DACRON SURGICAL SUTURES
- P880098MENICON SF-P RGP (MELAFOCON A) CONTACT LENS
- P890001LEOCOR,INC. MODELS 1
- P890002POLYPROPYLENE SURGICAL SUTURE
- P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071
- P890012SIGNATURE CONTACT LENS
- P890013RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300
- P890014HA-IGMK AND ETI-HA-IGMK
- P890017PALMAZ BALLOON EXPANDABLE STENT
- P890019AB -HAVK
- P890020FLUOROCON TM-60
- P890023H55 HYDROPHILIC CONTACT LENS
- P890024TROPHOCAN TM
- P890025TD CYCLOSPORINE AND METABOLITES SERUM ASSAY
- P890027NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDREN
- P890029EXCELENS (ATLAFILCON A) CONTACT LENS
- P890032CORDIS STEERABLE PTCA BALLOON CATHETER
- P890034MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR
- P890039MASTRO SAVVI SERIES 300 VDD PACING SYSTEM
- P890040SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS
- P890043SIMPSON CORONARY ATHEROCATH(TM)
- P890045GELSEAL TM TRIAXIAL VASCULAR GRAFT
- P890047PROVISC(TM)VISCOELASTIC PREPARATION
- P890048USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM
- P890049FINISHED METHAFILCON A CONTACT LENSES
- P890055MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM
- P890056MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS
- P890057MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR
- P890061VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE
- P890063GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM
- P890064VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KIT
- P890065CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS
- P890066THERASONIC LITHOTRIPSY TREATMENT SYSTEM
- P890068MODEL P-11 MODIFIED J-LOOP POSTERIOR CHAMBER IOL
- P890070PURE-DENT (R)
- P900007COOK CHORIONIC VILLUS SAMPLING SET
- P900009SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
- P900013ABBOTT PGR-EIA MONOCLONAL
- P900016MIRA-FLO STARCH
- P900022CHORUS DDD PACEMAKER
- P900023ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM
- P900025FLUORO-CEP (R) PROGESTERONE
- P900030CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT
- P900032AIS EXIMER LASER ANGIOPLASTY
- P900033INTEGRA DERMAL REGENERATION TEMPLATE
- P900037MODIFIED J&C LOOP POST. CHAMBER INTRAOCULAR LENS
- P900038PARASTEP-I
- P900039COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE
- P900042AWARE TEST SYSTEM
- P900043PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT
- P900048ELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM
- P900050ACCESS MOBILITY SYSTEM
- P900052PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEM
- P900053MODELS A21-A & A21-B POSTERIOR CHAMBER INTRAOCULAR
- P900056ROTABLATOR(R)
- P900060CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
- P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM
- P900066PERFLUOROPROPANE
- P900067SULFUR HEXAFLUORIDE
- P900070META DDDR PACING SYSTEM
- P910001SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
- P910007AXSYM TOTAL PSA & ARCHITECT TOTAL PSA
- P910016NEW JERSEY LCS(R) TOTAL KNEE SYSTEM
- P910018LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB…
- P910019IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
- P910020RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS
- P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM
- P910030GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)
- P910031ORACLE(TM) CORONARY BALLOON DILATATION CATHETER
- P910054INOUE BALLOON CATHETER
- P910056SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS
- P910058CHIROFLEX MODELS 32 C10XX SILICONE POSTERIOR IOL
- P910061MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS
- P910062VISX MODELB/MODEL C EXCIMER LASER SYSTEM
- P910063CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM
- P910064F C FEMALE CONDOM
- P910065AIA-PACK PSA
- P910066ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR
- P910067EXCIMED(TM) UV200LA LASER SYSTEM
- P910068VITREON(R)
- P910071ADATOMED SILICONE OIL OP5000
- P910073ENDOTAK LEAD SYSTEM
- P910077VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR
- P920004VASOSEAL (TM)
- P920006IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE
- P920011MAXIM PFS MODEL 033-301
- P920014HEARTMATE VE LVAS
- P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEM
- P920023UROLUME ENDOPROSTHESIS
- P920027ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II
- P920030CIBA CORNING ACS PSA IMMUNOASSAY
- P920031EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- P920032MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
- P920034TRIPTER-X1 NOVA
- P920038SYSTEM 37 HOME UTERINE ACTIVITY MONITORING SYSTEM
- P920046FILSHIE CLIP (MARK VI) SYSTEM
- P920047EPT-1000 CARDIAC ABLATION SYSTEM
- P920048FETAL FIBRONECTIN ENZYME IMMUNOASSAY KIT (EIK)
- P920051STORZ MODULITH (TM) LITHOTRIPTER
- P930014ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES
- P930016VISX EXCIMER LASER SYSTEM MODELS B AND C
- P930021BIORA EMDOGAIN(R)
- P930022MEDTRONIC(R) LEGEND PLUS(TM) PULSE GENERATOR
- P930024GRIESHABER SCLERAL BUCKLING BALLOON CATHETER
- P930027IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS
- P930029ATAKR(TM) RFCA SYSTEM
- P930030HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE
- P930031WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM
- P930034SVS APEX EXCIMER LASER SYSTEM
- P930035VENTAK(R) P2 SYSTEM
- P930036ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS
- P930038Angio Seal Vascular Closure Device
- P930039MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
- P940001GENESA(R) SYSTEM
- P940002NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)
- P940004ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI
- P940005ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM
- P940007PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL
- P940008RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL)…
- P940009PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH
- P940010OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
- P940011COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
- P940012600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG…
- P940013PRECISION(TM) UV (VASURFILCON)
- P940015SYNVISC ONE
- P940016H.E.L.P. SYSTEM
- P940019WALLSTENT(R) ILIAC ENDOPROSTHESIS
- P940022CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT
- P940024GUARDIAN(R) ATP II IMPLANTABLE CARDIOVERTER/DIFIB.
- P940029PAPNET (R) TESTING SYSTEM
- P940031VIGOR(TM) DR PACEMAKER SYSTEM
- P940033FEMIDOM
- P940034GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
- P940035NMP22 BladderChek Test
- P940036BARTELS CHEMORESPONSE ASSAY
- P940040AMPLICOR (TM) MYCOBACTERIUM TUBERCULOSIS TEST
- P950001SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
- P950002BAK INTERBODY FUSION SYSTEM
- P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER
- P950008SILIKON 1000
- P950009AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
- P950011TRUQUANT(R) BR(TM) RIA
- P950014PROSTATRON
- P950015THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION
- P950018PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)
- P950019RAY THREADED FUSION CAGE (TFC)(TM) WITH INSTRUMENTATION
- P950020FLEXATOME CUTTING BALLOON
- P950021ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY
- P950022TVL(TM) LEAD SYSTEM
- P950024MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
- P950027HYALGAN(R)
- P950029CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER
- P950032APLIGRAF (GRAFTSKIN)
- P950034SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
- P950035NEUROCONTROL FREEHAND SYSTEM(R)
- P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
- P950039THINPREP(R) PROCESSOR, MODEL TP 2000
- P950040DR. BROWN'S HOME DRUG TESTING KIT
- P950042PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA
- P950043ECONOLITH(TM) LITHOTRIPTER
- P960001DEPUY 1 BONE CEMENT
- P960004THINLINE ENDOCARDIAL PACING LEADS
- P960006SWEET TIP(R) RX STEROID ELUTING LEAD
- P960007TRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
- P960009MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
- P960010MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM
- P960011BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID
- P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
- P960014MAGELLAN-C PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY(PTCA) CATHETERS MODEL…
- P960016LIVEWIRE(R) CARDIAC ABLATION SYSTEM
- P960018THE NEEDLYZER - THE NEEDLE DESTROYER MODEL ND2
- P960019LASERVISION/VISX EXCIMER LASER MODEL C
- P960020RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE
- P960022SOFLENS66(TM)
- P960025BRANTIGEN I/F CAGE(R) USED WITH VSP(R) SPINE PLATES AND PEDICLE SCREWS
- P960028AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
- P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
- P960031PERIOGARD PERIODONTAL TISSUE MONITOR
- P960033STAARVISC TM SODIUM HYALURONATE
- P960034CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT.
- P960036MEMORYLENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL…
- P960039SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR)
- P960040VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE…
- P960042SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH
- P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
- P960044NEEDLE-EASE TM 2501
- P960047OSTEONICS CONSTRAINED ACETABULAR INSERT
- P960052DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)
- P960053BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS
- P960054S-ROM POLY-DIAL CONSTRAINED LINER
- P960057ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
- P960058CLARION MULTI-STRATEGY COCHLEAR IMPLANT
- P970002MONOSTRUT CARDIAC VALVE PROSTHESIS
- P970003VNS THERAPY SYSTEM
- P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL
- P970005KREMER LASER SYSTEM
- P970007IMX TACROLIMUS II ASSAY
- P970008TARGIS (T3) SYSTEM
- P970010NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT
- P970012MEDTRONIC.KAPPA 400 SERIES PACEMAKERS
- P970013MICRONY PACEMAKERS
- P970015INTER FIX THREADED FUSION DEVICE
- P970017SAHARA CLINICAL BONE SONOMETER
- P970018BD PREPSTAIN SYSTEM
- P970019HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
- P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMS
- P970021THERMACHOICE UTERINE BALLOON THERAPY(UBT) SYSTEM
- P970024ANGEION SENTINEL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)SYSTEM AND THE ANGEFLEX TM…
- P970025PRO-TRAC II TACROLIMUS ELISA KIT
- P970026MYRIAD ULTRASOUND SYSTEMS LTD. SOUNDSCAN
- P970027ABBOTT AXSYM ANTIBODY TO HCV
- P970029TMR HOLMIUM LASER SYSTEM
- P970030TORONTO SPV VALVE
- P970031MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS
- P970032SALEST TM SYSTEM
- P970033T-SCAN 2000
- P970034MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
- P970035AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY…
- P970036NIC 1800 NEEDLE DISPOSAL SYSTEM
- P970037AUTODELFIA HAFP TEST KIT
- P970038TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
- P970040ACHILLES EXPRESS ULTRASONOMETER
- P970042MEDSTONE STS LITHOTRIPTER
- P970043LADARVISION EXCIMER LASER SYSTEM
- P970044DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
- P970049DISHLER EXCIMER LASER SYSTEMS
- P970051NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- P970052FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS
- P970053EC-5000 EXCIMER LASER SYSTEM
- P970054BIOTRIN PARVOVIRUS B19 IGG
- P970055BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)
- P970056BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
- P970058M1000 IMAGECHECKER
- P970061SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM
- P970062GENESTONE 190 LITHOTRIPTER
- P980001NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM
- P980003CHILLI COOLED RF ABLATION SYSTEM
- P980006PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR
- P980007AXSYM FREE PSA
- P980008LASERSCAN LSX EXCIMER LASER SYSTEM
- P980009MAGIC WALLSTENT ENDOPROTHESIS
- P980010DTU-ONE ULTRASOUND SCANNER
- P980012NOVACOR LVAS
- P980015SHARPX
- P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS
- P980017PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20
- P980018DAKO HERCEPTEST
- P980020Q 103 NEEDLE MANAGEMENT SYSTEM
- P980022CONTINUOUS GLUCOSE MONITORING SYSTEM
- P980023PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
- P980024PATHVYSION HER-2 DNA PROBE KIT
- P980025LOGICON CARIES DETECTOR
- P980031INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
- P980033WALLSTENT ENDOPROSTHESIS
- P980035MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE
- P980037ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER
- P980040SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
- P980041ACCESS AFP IMMUNOASSAY SYSTEM
- P980043HANCOCK II PORCINE BIOPROSTHESIS
- P980044SUPARTZ FX
- P980046HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
- P980048BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM
- P980049DEFENDER II MODEL 9201 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
- P980050MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL…
- P980052TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
- P980053DURASPHERE INJECTABLE BULKING AGENT
- P990001DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2
- P990002FEMSOFT URETHRAL INSERT
- P990004SURGIFOAM ABSORBABLE GELATIN SPONGE, USP
- P990008COOK MBC PTCA BALLOON DILATATION CATHETER
- P990009FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT
- P990010VISX EXCIMER LASER SYSTEM MODEL C STAR
- P990012ELECSYS HBSAG IMMUNOASSAY, ELECSYS HBSAG CONFIRMATORY, AND PRECICONTROL HBSAG
- P990013COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
- P990014HYDROVIEW COMPOSITE HYDROGEL FOLDABLE UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
- P990015INTERGEL ADHESION PREVENTION SOLUTION
- P990016MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0
- P990017ANCURE(TM) TUBE SYSTEM, ANCURE(TM) BIFURCATED SYSTEM
- P990018MENICON Z RIGID GAS PERMEABLE CONTACT LENS
- P990019BLU -U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR
- P990020ANEURX STENT GRAFT SYSTEM
- P990021DIOMED 630 PDT LASER
- P990023CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE
- P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER
- P990026GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- P990027TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
- P990028FOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT
- P990030VITAGEL SURGICAL HEMOSTAT
- P990033PEPGEN P-15
- P990034MEDTRONIC ISOMED INFUSION SYSTEM
- P990035THE SUNLIGHT OMNISENSE(TM) ULTRASOUND BONE SONOMETER
- P990036CORDIS CHECKMATE(TM) SYSTEM
- P990037VASCULAR SOLUTIONS DUETT SEALING DEVICE
- P990038DIASORIN ETI MAK-2 PLUS ASSAY
- P990039QUS-2 (TM) CALCANEAL ULTRASONOMETER
- P990040TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM
- P990041DIASORIN ETI-AB-EBK PLUS ASSAY
- P990042DIASORIN ETI-AB-AUK PLUS ASSAY
- P990043DIASORIN ETI-EBK PLUS ASSAY
- P990044DIASORIN ETI-CORE-IGMK PLUS ASSAY
- P990045DIASORIN ETI-AB-COREK PLUS ASSAY
- P990046ATS OPEN PIVOT BILEAFLET HEART VALVE
- P990048ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER
- P990049COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM
- P990050OPTICAL BIOPSY(TM) SYSTEM
- P990052VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM
- P990053OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- P990054CHILLI COOLED ABLATION SYSTEM
- P990055BAYER IMMUNO 1 COMPLEXED PSA ASSAY
- P990056ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
- P990064MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC HEART VALVE
- P990065SIR-SPHERES
- P990066GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- P990069ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE…
- P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
- P990072W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES
- P990074NATRELLE SALINE BREAST IMPLANTS
- P990075MENTOR CORPORATION SALINE-FILLED AND SPECTRUM (R) MAMMARY PROSTHESES
- P990078HYPERION LTK SYSTEM
- P990080CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL…
- P990081PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY
- P990085VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH…
- 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