Atlas FDA

1996

484 FDA 510(k) clearances · PMA decision year

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◉ Watch 1996

RecordFirmDate
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S069)Biomerieux Vitek, Inc.1996-08-07
MEDTRONIC SPRINT TM MODEL 6932 LEAD (P920015/S010)Medtronic, Inc.1996-08-06
MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S028)Medtronic Cardiac Rhythm Disease Management1996-08-06
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT VERSION 1.2 (P940022/S001)Advanced Bionics Corp.1996-08-02
VASOSEAL (TM) (P920004/S001)St. Jude Medical, Inc.1996-08-01
BARTELS CHEMORESPONSE ASSAY (P940036)Bartels Prognostics, Inc.1996-08-01
POSTERIOR CHAMBER INTROCULAR LENSES (P830056/S077)Carl Zeiss Meditec, AG1996-08-01
HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES (P850079/S028)CooperVision, Inc.1996-08-01
VASOSEAL (TM) (P920004/S002)St. Jude Medical, Inc.1996-08-01
UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR (P910020/S012)Boston Scientific1996-07-31
OSTEOBOND(TM) COPOLYMER BONE CEMENT (N17755/S047)Zimmer, Inc.1996-07-31
MEDTRONIC MODELS 8616-10 & 8617-10(ALSO REFERRED TO AS MODELS 8631 & 8635) SYNCHROMED(R) IMPLANT.PROGRAM. INFUSION PUMP (P860004/S022)Medtronic, Inc.1996-07-29
SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH (P810046/S161)Advanced Cardiovascular Systems, Inc.1996-07-29
MEDTRONIC SPRINT TM MODEL 6932 LEAD (P920015/S011)Medtronic, Inc.1996-07-26
THOR PTCA DILATION CATHETERS (P880003/S060)Cordis Corp.1996-07-26
META DDDR PACING SYSTEM (P900070/S009)St. Jude Medical, Cardiac Rhythm Management Divisi1996-07-23
REFLEX MODEL 8223E (P820018/S065)St. Jude Medical, Inc.1996-07-23
MEDA-MV PACING SYSTEM (P880038/S028)St. Jude Medical, Inc.1996-07-23
AUTIMA/AURORA CARDIAC PACING SYSTEM (P820018/S063)St. Jude Medical, Inc.1996-07-23
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S003)Pace Medical1996-07-19
EZE-FIT(TM) (P840039/S048)Bausch & Lomb, Inc.1996-07-18
PRO OSTEON IMPLANT 500 CORALLINE HYDROXYPATITE BONE VOID FILLER (FORMERLY INTERPORE 500) (P860005/S005)Interpore Intl.1996-07-18
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S005)Ge Medical Systems, Inc.1996-07-17
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM-ADDITION OF THREE PEGGED PATTELLA PROSTHESES (P830055/S046)Depuy, Inc.1996-07-17
MEDTRONIC MODEL 5348 TEMPORARY PACEMAKER KEYPAD COMPONENT (P820003/S073)Medtronic Cardiac Rhythm Disease Management1996-07-16
CLARIS(R) CLEANING AND SOAKING SOLUTION (P870023/S007)Advanced Medical Optics, Inc.1996-07-12
H55 HYDROPHILIC CONTACT LENS/OCUFILCON D 55% HYDRO. CONTACT LENSES (P890023/S003)The Cooper Companies1996-07-12
IMMULITE(R) THIRD GENERATION PSA (P930027/S001)Siemens Healthcare Diagnostics, Inc.1996-07-11
MEDA-MV PACING SYSTEM (P880038/S029)St. Jude Medical, Inc.1996-07-11
META DDDR PACING SYSTEM (P900070/S010)St. Jude Medical, Cardiac Rhythm Management Divisi1996-07-11
REFLEX MODEL 8223E (P820018/S066)St. Jude Medical, Inc.1996-07-11
THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S001)Thoratec Laboratories Corp.1996-07-10
STERILE SALINE PRESERVED SOLUTION (P850070/S008)Automatic Liquid Packaging, Inc.1996-07-10
MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM (P860027/S011)Cardiac Control Systems, Inc.1996-07-09
MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333 (P890039/S015)Cardiac Control Systems, Inc.1996-07-09
DIAPHRAGMATIC PACEMAKER PHRENIC NERVE STIMULATOR (P860026/S005)Avery Biomedical Devices, Inc.1996-07-09
NMP22 BladderChek Test (P940035)Abbott Diagnostics Scarborough, Inc.1996-07-02
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S010)Corcym S.r.l.1996-07-02
GOLDIE(TM) AND GOLDIE(TM) LONGY PTCA CATHETERS (P880027/S039)Boston Scientific1996-07-01
SCIMED(R) SURPASS(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (P860019/S111)Scimed Life Systems, Inc.1996-07-01
MEDTRONIC MODEL 7221 B/C/CX/D/E MICRO JEWEL W/MODEL 5434 ACTIVE CAN EMULATOR AND MODEL 9894 (P900061/S022)Medtronic Cardiac Rhythm Disease Management1996-07-01
UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S (P880091/S006)Staar Surgical Co.1996-07-01
MEDTRONIC THERA, PRODIGY AND PREVA PULSE GENERATORS (P890003/S043)Medtronic, Inc.1996-07-01
M3000 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE (P890055/S001)Intera Oncology1996-06-27
NETWORK PROGRAMMER MODEL 9602 (P900070/S012)St. Jude Medical, Cardiac Rhythm Management Divisi1996-06-25
NETWORK PROGRAMMER MODEL 9602 (P880038/S031)St. Jude Medical, Inc.1996-06-25
NETWORK PROGRAMMER MODEL 9602 (P820018/S069)St. Jude Medical, Inc.1996-06-25
VISCOAT VISCOELASTIC SOLUTION (P840064/S017)Alcon Laboratories1996-06-21
STORZ MODULITH LITHOTRIPTER, MODEL SLX (P920051/S003)KARL STORZ Endoscopy-America, Inc.1996-06-21
LITHOSTAR (P870018/S016)Siemens Corp.1996-06-21
META DDDR PACING SYSTEM (P900070/S011)St. Jude Medical, Cardiac Rhythm Management Divisi1996-06-21
PROVISC VISCOELASTIC MATERIAL (P890047/S010)Alcon Research, Ltd.1996-06-21
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S063)Cochlear Americas1996-06-20
PROSTATRON (P950014/S001)Urologix, Inc.1996-06-20
CLARIS(TM) REWETTING DROPS (P900047/S005)Advanced Medical Optics, Inc.1996-06-20
VISTA DDD MODEL 942 & 944 AND SOFTWARE MODULE MODEL 2052 (P840068/S019)Boston Scientific1996-06-19
FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM (P870076/S004)Gyrus Acmi, Inc.1996-06-14
LEOCOR PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP (P890001/S011)Leocor, Inc.1996-06-13
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S064)Cochlear Americas1996-06-13
LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED) (P890001/S014)Leocor, Inc.1996-06-13
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S032)Cochlear Americas1996-06-13
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S033)Cochlear Americas1996-06-13
CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY DILATATION CATHETERS (P880003/S054)Cordis Corp.1996-06-13
ASUKA AND ASUKA LONGY OVER-THE-WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS (P880027/S038)Boston Scientific1996-06-12
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S014)ABBOTT MEDICAL1996-06-11
CADET TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S018)ABBOTT MEDICAL1996-06-11
ATAKR RFCA SYSTEM (P930029/S005)Medtronic, Inc.1996-06-11
SCIMED WAVE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) (P860019/S108)Scimed Life Systems, Inc.1996-06-10
LEOCOR PICO RUNNER(TM) PTCA CATHETER (P890001/S015)Leocor, Inc.1996-06-07
LITHOSTAR LITHOTRIPTER SHOCK WAVE SYSTEM C (P870018/S014)Siemens Corp.1996-06-06
ONE PIECE POSTERIOR CHAMBER IOL (P840039/S049)Bausch & Lomb, Inc.1996-06-05
CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS (P880003/S059)Cordis Corp.1996-06-05
MOBILE LITHOSTAR WITH SHOCK WAVE SYSTEM C (SWSC) (P870018/S015)Siemens Corp.1996-06-05
ONE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV NEW LENS CARRIER (P880090/S017)Bausch & Lomb, Inc.1996-06-05
GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST) (P940034/S002)Gen-Probe, Inc.1996-06-05
ONE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENSES (P860002/S017)Bausch & Lomb1996-06-05
ALCON WETTING, SOAKING, CONDITIONING, AND DISINFECTING SOLUTION ID 84392 (P830071/S006)Alcon Laboratories1996-06-04
UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P860059/S075)Advanced Medical Optics, Inc.1996-05-30
CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER (P910031/S007)Abbott Vascular Devices1996-05-30
RX5000 PROGRAMMER MODEL 522-12 (P830026/S065)Boston Scientific1996-05-30
HAVAB-M DIAGNOSTIC KIT (P790019/S006)Abbott Laboratories1996-05-29
HAVAB-M EIA DIAGNOSTIC KIT (P790019/S007)Abbott Laboratories1996-05-29
WALLSTENT(R) ILIAC ENDOPROSTHESIS (P940019)Boston Scientific Scimed, Inc.1996-05-28
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S024)Medstone Intl., Inc.1996-05-24
PROGRESSIVE ANGTIOPLASTY SYSTEMS (PAS) CHAMPION PTCA CORONARY DILATATION CATHETER (P930012/S003)Progressive Angioplasty Systems, Inc.1996-05-22
INTERTACH(R) FAMILY OF PULSE GENERATORS (P860007/S016)Boston Scientific1996-05-21
THINPREP(R) PROCESSOR, MODEL TP 2000 (P950039)Hologic, Inc.1996-05-20
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S031)Cochlear Americas1996-05-20
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S062)Cochlear Americas1996-05-20
PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL/FOLDABLE IOL MODEL 127(920) (P940007/S001)Advanced Medical Optics, Inc.1996-05-20
PALMAZ BALLOON-EXPANDABLE STENT/ILIAC ARTERIES (P890017/S004)Cordis US Corporation1996-05-20
UVAR PHOTOPHORESIS SYSTEM (P860003/S027)Therakos Development Limited1996-05-17
ABBOTT HBE (RDNA) EIA (P790025/S006)Abbott Laboratories1996-05-17
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S014)Boston Scientific Corp1996-05-16
SURGICEL FIBRILLAR ABSORBABLE HEMOSTATT (N12159/S016)ETHICON, Inc.1996-05-15
ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD (P910073/S020)Boston Scientific1996-05-15
VENTAK PRX AICD, VENTAK PRX II AICD, VENTAK PRX III AICD, VENTAK MINI AICD, VENTAK MINI HC AICD, VENTAK II AICD (P910077/S015)Boston Scientific1996-05-15
VENTAK P2 AICD MODEL 1625 & VENTAK P3 AICD MODELS 1630 AND 1635 (P930035/S005)Boston Scientific1996-05-15
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S042)ABBOTT MEDICAL1996-05-14
USCI GRUNTZIG DILICA CORONARY ARTERY BALLOON DILATATION CATHETER & USCI PROCROSS ELITE OVER THE WIRE W/PRO/PEL COATING (P790017/S058)Medtronic, Ireland1996-05-13
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Track 1996 automatically

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