Atlas FDA

1996

484 FDA 510(k) clearances · PMA decision year

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◉ Watch 1996

RecordFirmDate
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S013)ABBOTT MEDICAL1996-05-13
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE AND VALVED CONDUITS (P790018/S024)Medtronic Cardiac Surgery1996-05-13
TVL(TM) LEAD SYSTEM (P950022)ABBOTT MEDICAL1996-05-10
SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285 (P950001)Boston Scientific1996-05-08
CADET(TM) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S019)ABBOTT MEDICAL1996-05-07
MEDTRONIC MODELS 7200B/C/D/E (P900061/S017)Medtronic Cardiac Rhythm Disease Management1996-05-07
UROLUME ENDOPROSTHESIS (P920023)Boston Scientific Corp1996-05-06
CORDIS PTCA DILATATION CATHETER, TITAN AND TITAN XL PTCA DILATATION CATHETERS (P880003/S057)Cordis Corp.1996-05-06
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES (P830055/S047)Depuy, Inc.1996-05-06
PROSTATRON (P950014)Urologix, Inc.1996-05-03
TANDEM-R PSA & TANDEM-E PSA IMMUNOENZYMETRIC ASSAY (P850048/S012)Beckman Coulter, Inc.1996-05-03
MARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-66 (P910020/S013)Boston Scientific1996-05-03
MICROSCAN (R) RAPID FLUOROGENIC PANELS-GENTAMICIN GRAM NEGATIVE PANELS (P870049/S025)Dade Intl., Inc.1996-05-03
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S018)Abiomed Cardiovascular, Inc.1996-05-02
PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT (P900043/S002)Cordis Corp.1996-05-01
THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S002)Thoratec Laboratories Corp.1996-05-01
POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES (P870013/S008)Bausch & Lomb1996-05-01
POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES (P790027/S059)Bausch & Lomb1996-05-01
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S040)ABBOTT MEDICAL1996-05-01
POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENS (P850059/S016)Bausch & Lomb Surgical, Inc.1996-05-01
VENTAK(R) MINI HC(HOT CAN) AICD SYSTEM (P910077/S012)Boston Scientific1996-04-29
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S016)ABBOTT MEDICAL1996-04-26
MICRO-PACE MODEL 4553 DUAL CHAMBER DDD TEMPORARY CARDIAC PACEMAKER (P920032/S002)Pace Medical1996-04-26
AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM (P950009/S001)Bd Diagnostics1996-04-25
POSTERIOR CHAMBER INTRAOCULAR LENSES MODELS PA38E-OUV AND PL52A-OUV (P880072/S042)Eyekon Medical, Inc.1996-04-24
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S001)Gen-Probe, Inc.1996-04-23
CORDIS PTCA DILATATION CATHETER AND CORDIS VALOR AND VALOR XL PTCA DILATATION CATHETERS (P880003/S055)Cordis Corp.1996-04-23
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM'S DYNAGLIDE(TM) FOOT PEDAL (P900056/S015)Boston Scientific Corp1996-04-23
AUTIMA AURORA CARDIAC PACING SYSTEM (P820018/S067)St. Jude Medical, Inc.1996-04-23
CORDIS PTCA DILATATION CATHETERS AND CORDIS THOR PTCA DILATATION CATHETERS (P880003/S056)Cordis Corp.1996-04-23
SORBIC ACID PRESERVED SALINE SOL.PH CHANGE (P870007/S010)Optopics Laboratories Corp.1996-04-22
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S070)Biomerieux Vitek, Inc.1996-04-22
USCI(R)GRUNTZIG DILACA CATHETER (P790017/S052)Medtronic, Ireland1996-04-18
MODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P880072/S040)Eyekon Medical, Inc.1996-04-17
VISTA 4, 6, & T; DELTA T & TRS; VISTA DD; AND VIGOR DDD (P840068/S026)Boston Scientific1996-04-16
EXTENSION TO THE PAS LACROSSE PTCA CATHETER PRODUCT LINE (P930012/S002)Progressive Angioplasty Systems, Inc.1996-04-16
JEWEL(TM) MODELS 7219 B/D/E, 7202 B/D/E JEWEL PLUS 7220 B/D/E (P900061/S013)Medtronic Cardiac Rhythm Disease Management1996-04-15
WET-N-SOAK(TM) REWETTING DROPS (P900047/S003)Advanced Medical Optics, Inc.1996-04-12
OXYSEPT 1 & ULTRACARE DISINFECTING SOLUTIONS & OXYSEPT 2 NEUTRALIZING SOLUTION (P850088/S033)Advanced Medical Optics, Inc.1996-04-12
WET-N-SOAK (P870037/S007)Advanced Medical Optics, Inc.1996-04-12
LENS-WET(TM) (P800065/S014)Advanced Medical Optics, Inc.1996-04-12
ALLERGAN(R) REWETTING DROPS (P910075/S005)Advanced Medical Optics, Inc.1996-04-12
EASYCLEAN/GP, LC-65, LENS CLEAR, AND LENS PLUS, DAILY CLEANERS (P790024/S024)Advanced Medical Optics, Inc.1996-04-12
ALLERGAN HYDROCARE PRESERVED SALINE SOLUTION, SORBICARE SALINE, AND PRESERVED SALINE (N18020/S039)Advanced Medical Optics, Inc.1996-04-12
ALLERGAN(R) HYDROCARE(R) CLEAN & DISINFECT SOLUTIO (N17786/S024)Advanced Medical Optics, Inc.1996-04-12
TCI HEARTMATE(R) 1000A IP LVAD (P920014/S003)Thoratec Corp1996-04-12
RESOLVE/GP(TM) DAILY CLEANER (P870026/S006)Advanced Medical Optics, Inc.1996-04-12
CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS (P880003/S053)Cordis Corp.1996-04-12
ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM (P940005)Advanced Technology Laboratories, Inc.1996-04-11
DORNIER LITHOTRIPTER MOBILE (P840008/S053)Dornier Medtech America, Inc.1996-04-11
AMO(R) VITRAX(R) VISCOELASTIC SOLUTION (P880031/S009)Abbott Medical Optics, Inc.1996-04-09
EBI BONE HEALING SYSTEM(R) (P790002/S016)Ahp Eos Buyer, Inc.1996-04-09
AMO VITRAX (SODIUM HYALURONATE) (P880031/S010)Abbott Medical Optics, Inc.1996-04-08
MODEL PA48A-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P880072/S039)Eyekon Medical, Inc.1996-04-08
MEDTRONIC TRANSVENE LEAD SYSTEM (P920015/S009)Medtronic, Inc.1996-04-08
VERSAFLEX; BUCHBINDER, OMNIFLEX PTCA CATHETER SYSTEMS MEDTRONIC 18K, 14K, EVERGREEN, FALCON, PANTHER, AND SPIRIT PTCAR (P870036/S036)Medtronics Interventional Vascular1996-04-08
ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 0063 (P910073/S016)Boston Scientific1996-04-04
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S030)Cochlear Americas1996-04-04
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S061)Cochlear Americas1996-04-04
MENICON SF-P (MELAFOCON A) CONTACT LENS (P880098/S009)Menicon Co, Ltd.1996-04-03
POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S075)Carl Zeiss Meditec, AG1996-04-02
ENDOTAK(R) LEAD SYSTEM (P910073/S018)Boston Scientific1996-04-02
PAS LACROSSE TM PTCA CATHETER (P930012/S001)Progressive Angioplasty Systems, Inc.1996-04-02
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A (P900009/S002)Bioventus, LLC1996-04-02
COSMOS FAMILY OF PULSE GENERATORS (P830026/S064)Boston Scientific1996-04-01
TDX CYCLOSPORINE AND METABOLITES SERUME ASSAY (P890025/S009)Abbott Laboratories1996-04-01
ENDOTAK(R) LEAD SYSTEM/MODEL 6952 LEAD EXTENDER (P910073/S019)Boston Scientific1996-04-01
TRUQUANT(R) BR(TM) RIA (P950011)Biomira, Inc.1996-03-29
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 (P930039)Medtronic, Inc.1996-03-29
VISX EXCIMER LASER SYSTEM MODELS B AND C (P930016)Amo Manufacturing USA, LLC1996-03-27
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S060)Cochlear Americas1996-03-26
DUOVISC VISCOELASTIC SYSTEM (P840064/S016)Alcon Laboratories1996-03-26
NCRYSOF (R) UV ABSORBING INTRAOCULAR LENSES (P930014/S002)Alcon Laboratories, Inc.1996-03-26
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S029)Cochlear Americas1996-03-26
DUOVISC VISCOELASTIC SYSTEM (P890047/S009)Alcon Research, Ltd.1996-03-26
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (P940022)Advanced Bionics Corp.1996-03-22
DUOVISC VISCOELASTIC SYSTEM (P890047/S008)Alcon Research, Ltd.1996-03-22
VISCOAT VISCOELASTIC SYSTEM (P840064/S015)Alcon Laboratories1996-03-22
MEDTRONIC(R) THERA(R) VDD, MODEL 896I, PRODIGY(TM) VDD, MODEL 8168 PULSE GENERATORS AND CAPURE(R) VDD, MODEL 5032 LEAD, (P890003/S039)Medtronic, Inc.1996-03-22
INTERTACH(R)II MODELS 262-16 (P860007/S017)Boston Scientific1996-03-22
VIGOR MODEL 2880 SOFTWARE APPLICATION (P840068/S028)Boston Scientific1996-03-22
RELAY/DASH/STRIDE/DART PACING SYSTEMS (P910020/S011)Boston Scientific1996-03-22
MEDTRONIC(R) MODEL 6937 TRANSVENE SVC LEAD (P920015/S005)Medtronic, Inc.1996-03-22
RX5000(TM) PROGRAMMER (P830026/S066)Boston Scientific1996-03-22
RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS (P940008/S001)Boston Scientific1996-03-21
MECHANICAL HEART VALVE SJM(R) MASTER SERIES (EXPANDED SEWING CUFF) (P810002/S039)ABBOTT MEDICAL1996-03-21
VIGOR(TM) DR PACEMAKER SYSTEM (P940031/S003)Boston Scientific1996-03-21
FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES (P820021/S028)Alcon Laboratories, Inc.1996-03-18
RELAY/DASH/STRIDE/DART PACING SYSTEMS (P910020/S010)Boston Scientific1996-03-15
VENTAK(R) PRX(R) AICD(TM) SYSTEM FOR PECTORAL REPLACEMENT OF VENTAK PRXIII PULE GENERATOR (P910077/S009)Boston Scientific1996-03-14
ORACLE(TM) CORONARY BALLOON DILATATION CATHETER (P910031/S005)Abbott Vascular Devices1996-03-13
MEDTRONIC MODEL 9751C SYS. ENHANCEMENT MODULE (P820003/S071)Medtronic Cardiac Rhythm Disease Management1996-03-13
MEDTRONIC(R) MODEL 6934S TRANSVENE RV LEAD (P920015/S007)Medtronic, Inc.1996-03-13
TCI HEARTMATE(R) 1000A IP LVAS (P920014/S004)Thoratec Corp1996-03-13
LITHOSTAR (P870018/S013)Siemens Corp.1996-03-13
MECHANICAL HEART VALVE SJM(R) MASTER SERIES (P810002/S038)ABBOTT MEDICAL1996-03-13
MEDTRONIC SINGLE CHAMBER PACEMAKERS (P850051/S052)Medtronic, Inc.1996-03-13
TITAN AND TITAN XL PTCA DILATATION CATHETERS (P880003/S052)Cordis Corp.1996-03-13
DELTA PACEMAKER SYSTRM; VIGOR DDD MODEL 950 (MASTER) (P840068/S027)Boston Scientific1996-03-12
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S024)Dade Intl., Inc.1996-03-12
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Track 1996 automatically

Every clearance here is in the API, with alerts when new ones post.