Atlas FDA

1995

496 FDA 510(k) clearances · PMA decision year

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◉ Watch 1995

RecordFirmDate
MODEL PS50C-OUV (P880072/S035)Eyekon Medical, Inc.1995-08-07
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S018)Cordis Corp.1995-08-04
CORDIS PTCA DILITATION CARTHETERS (P880003/S025)Cordis Corp.1995-08-04
VENTAK(R) PRX(R) AICD(TM) SYSTEM (P910077/S004)Boston Scientific1995-08-03
DUOVISC VISCOELASTIC SYSTEM (P890047/S007)Alcon Research, Ltd.1995-08-02
DUOVISC VISCOELASTIC SYSTEM (P840064/S014)Alcon Laboratories1995-08-02
NDS LENS MAINTENANCE SYSTEM (P900029/S001)Ciba Vision Corporation1995-08-01
MODEL 5420 PATIENT CABLE (P900061/S016)Medtronic Cardiac Rhythm Disease Management1995-08-01
JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM (P900061/S011)Medtronic Cardiac Rhythm Disease Management1995-08-01
ENDOTAK(R) LEAD SYSTEM (P910073/S007)Boston Scientific1995-08-01
REALITY FEMALE CONDOM (P910064/S010)The Female Health Co.1995-07-31
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S035)ABBOTT MEDICAL1995-07-31
MEDTRONIC(R) THERA(TM) PULSE GENERATORS (P890003/S036)Medtronic, Inc.1995-07-31
ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES (P900059/S001)Molecular Biosystems, Inc.1995-07-31
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S005)Spectranetics Corp.1995-07-31
REALITY FEMALE CONDOM (P910064/S007)The Female Health Co.1995-07-31
REALITY FEMALE CONDOM (P910064/S008)The Female Health Co.1995-07-31
SCHNEIDER FREEHAND(R) PTCA CATHETERS (P880027/S037)Boston Scientific1995-07-31
5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL (P880081/S018)Johnson & Johnson Surgical Vision, Inc.1995-07-28
MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL (P860034/S012)Advanced Medical Optics, Inc.1995-07-28
MODIFIED J & C LOOP MODELS PA15,30,35,36,48,58 (P880072/S021)Eyekon Medical, Inc.1995-07-28
MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS (P890056/S002)Advanced Medical Optics, Inc.1995-07-28
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S028)Cochlear Americas1995-07-28
MODELS PC-58NBM & PC-58NBZ IOLS (P820049/S061)Advanced Medical Optics, Inc.1995-07-28
VANTAGE (TETRAFILCON A ) CONTACT LENS (N17679/S029)CooperVision, Inc.1995-07-28
REALITY FEMALE CONDOM (P910064/S004)The Female Health Co.1995-07-24
LASER WELDING REVERSE HAPTIC ASPECT RATIO (P880010/S017)Alcon Laboratories1995-07-24
UV ABSORBING POSTERIOR CHAMBER IOL (P810018/S034)Alcon Laboratories1995-07-24
MODIFIED J & C LOOP MODEL PA36 (P880072/S027)Eyekon Medical, Inc.1995-07-24
ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING (P800049/S006)Alcon1995-07-24
REALITY FEMALE CONDOM (P910064/S001)The Female Health Co.1995-07-24
MODIFIED J & C LOOP MODEL PA36 (P880072/S026)Eyekon Medical, Inc.1995-07-24
MODIFIED J & C LOOP MODEL PA36 (P880072/S032)Eyekon Medical, Inc.1995-07-24
ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING (P810001/S011)Alcon1995-07-24
MODIFIED J & C LOOP MODEL PA36 (P880072/S029)Eyekon Medical, Inc.1995-07-24
3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV (P830040/S024)Alcon Research, Ltd.1995-07-24
POSTERIOR CHAMBER IOL (P840060/S023)Alcon Laboratories1995-07-24
MODIFIED J & C LOOP MODEL PA36 (P880072/S028)Eyekon Medical, Inc.1995-07-24
REALITY FEMALE CONDOM (P910064/S009)The Female Health Co.1995-07-24
ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING (P820035/S013)Alcon1995-07-24
UV ABSORBING POST.CHAM.IOL (P810032/S047)Alcon Laboratories1995-07-24
MODIFIED J & C LOOP MODEL PA36 (P880072/S033)Eyekon Medical, Inc.1995-07-24
REALITY FEMALE CONDOM (P910064/S006)The Female Health Co.1995-07-24
OXYCELL (N5798/S007)Bd Becton Dickinson Vacutainer Systems Preanalytic1995-07-24
ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING (P880087/S005)Alcon Laboratories1995-07-24
NCRYSOF (R) UV ABSORBING INTRAOCULAR LENSES (P930014/S001)Alcon Laboratories, Inc.1995-07-24
PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL (P940007)Advanced Medical Optics, Inc.1995-07-20
HYSKON (32% DEXTRAN 70) (N17511/S010)Coopervision Surgical1995-07-18
HYSKON (32% DEXTRAN 70) (N17511/S011)Coopervision Surgical1995-07-18
OCUCOAT (2% HYDROXYPROPYLMETHYLCELLULOSE) (P860047/S010)Bausch & Lomb, Inc.1995-07-18
ADATO SIL 5000 (P910071/S002)Bausch & Lomb1995-07-14
LITHOSTAR (P870018/S010)Siemens Corp.1995-07-13
MEDTRONIC ITREL(R) & ITREL(R) SPINAL CORD STIM SYS (P840001/S036)Medtronic Neuromodulation1995-07-13
ROTABLATOR(R) (P900056/S006)Boston Scientific Corp1995-07-12
KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS. (P870054/S014)Cook Pacemaker Corp.1995-07-12
AUTIMA/AURORA CARDIAC PACING SYSTEM (P820018/S061)St. Jude Medical, Inc.1995-07-12
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S008)Spectranetics Corp.1995-07-12
ABBOTT ER-EIA MONOCLONAL DIAG. KIT (P850029/S001)Abbott Laboratories1995-07-12
HYBRID (PTCA) CATHETER (P850021/S030)Abbott Vascular, Inc.1995-07-12
ABBOTT CEA-RIA MONOCLONAL (P830066/S012)Abbott Laboratories1995-07-12
SIMPSON CORONARY ATHEROCATH(TM),SCA-EX(TM), SCA-EX 7 FRENCH GRAFT AND ATHEROCATH-GTO(R) (P890043/S028)Abbott Vascular1995-07-12
META DDDR PACING SYSTEM (P900070/S007)St. Jude Medical, Cardiac Rhythm Management Divisi1995-07-12
ABBOTT PGR-EIA MONOCLONAL (P900013/S001)Abbott Laboratories1995-07-07
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A (P900009/S001)Bioventus, LLC1995-07-07
INSTAT COLLAGEN ABSORBABLE HEMOSTAT (P830079/S011)ETHICON, Inc.1995-07-07
VASCUTEK GELSOFT(TM) VASCULAR GRAFT (P890045/S001)Carbomedics, Inc.1995-07-05
FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES (P820021/S027)Alcon Laboratories, Inc.1995-06-28
MENICON SF-P (MELAFOCON A) CONTACT LENS (P880098/S008)Menicon Co, Ltd.1995-06-23
ATAKR(TM) RFCA SYSTEM AND THR RF MARINR NTC (P930029/S002)Medtronic, Inc.1995-06-23
JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM (P900061/S009)Medtronic Cardiac Rhythm Disease Management1995-06-23
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S015)Abiomed Cardiovascular, Inc.1995-06-22
CMW ORTHOPEDIC BONE CEMENT (N18466/S016)Depuy, Inc.1995-06-21
SYNCHRONY(R) CARDIAC PACING SYSTEM (P880086/S031)ABBOTT MEDICAL1995-06-21
VIGOR(TM) DR PACEMAKER SYSTEM (P940031)Boston Scientific1995-06-21
ZYDERM COLLAGEN IMPLANT (ZYDERM CI) (P800022/S023)Allergan1995-06-16
GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM) (P890063/S004)Matria Healthcare, Inc.1995-06-16
USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S004)Usci, Div. C.R. Bard, Inc.1995-06-14
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S004)Covidien1995-06-14
ACS RX LIFESTREAM(TM) CORONARY DILATATION CATHETER (P810046/S154)Advanced Cardiovascular Systems, Inc.1995-06-14
USCI(R) GRUNTZIG DILACA CATHETER (P790017/S056)Medtronic, Ireland1995-06-12
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S030)Abbott Vascular1995-06-12
MODEL 3100/3100A HIGH FREQUENCY OCILLATORY VENT. (P890057/S004)ZOLL Medical Corporation1995-06-12
HYBRID (PTCA) CATHETER (P850021/S031)Abbott Vascular, Inc.1995-06-12
HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R) (P860047/S009)Bausch & Lomb, Inc.1995-06-09
ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT (N17755/S042)Zimmer, Inc.1995-06-09
ACS CORONARY DILITATION CATHETER (P810046/S155)Advanced Cardiovascular Systems, Inc.1995-06-07
SYNCHRONY(R) CARDIAC PACING SYSTEM (P880086/S028)ABBOTT MEDICAL1995-06-07
ENDOTAK(R) LEAD SYSTEM (P910073/S014)Boston Scientific1995-06-07
SCHNEIDER SHORTGOOSE NONCOMPLIANT CATHETER (P880027/S034)Boston Scientific1995-06-05
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S042)Cordis Corp.1995-06-05
VIGOR SSI PACEMAKER SYSTEM (P840068/S024)Boston Scientific1995-06-05
MEDTRONIC SYNCHROMED INFUSION SYSTEM (P860004/S033)Medtronic, Inc.1995-06-05
ORACLE(TM) CORONARY BALLOON DILATATION CATHETER (P910031/S001)Abbott Vascular Devices1995-06-05
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S044)Cordis Corp.1995-06-05
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S043)Cordis Corp.1995-06-05
BOSTON EQUALENS(R) AND BOSTON RXD(R) (P860022/S046)Bausch & Lomb1995-06-05
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S045)Cordis Corp.1995-06-05
BOSTON EQUALENS(R) AND BOSTON RXD(R) (P860022/S047)Bausch & Lomb1995-06-05
GORE-TEX(R) SUTURE (P820083/S020)W. L. Gore & Associates, Inc.1995-06-05
MODELS PCUB-30SEO AND PCUB-32SEO IOL (P830033/S026)Advanced Vision Science1995-06-05
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Track 1995 automatically

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