Atlas FDA

1995

496 FDA 510(k) clearances · PMA decision year

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◉ Watch 1995

RecordFirmDate
MODELS PS-100A,PS-101A,PS-102A,PS-103A,PS-104A IOL (P820049/S059)Advanced Medical Optics, Inc.1995-06-01
VENTAK(R) P3 AICD(TM) SYSTEM (P930035/S002)Boston Scientific1995-05-25
ULTRAZYME(R) ENZYMATIC CLEANER (P860061/S009)Advanced Medical Optics, Inc.1995-05-25
ATAKR(TM) RFCA SYSTEM (P930029/S003)Medtronic, Inc.1995-05-25
SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN (P850077/S021)CooperVision, Inc.1995-05-25
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S046)Allergan1995-05-24
MEDTRONIC SINGLE CHAMBER PACEMAKERS (P850051/S050)Medtronic, Inc.1995-05-23
MEDTRONIC(R) THERA(TM) PULSE GENERATORS (P890003/S038)Medtronic, Inc.1995-05-23
ROTABLATOR(R) (P900056/S008)Boston Scientific Corp1995-05-22
MODELS 121UV & S121UV ULTRAVIOLET-ABSORBING LENSES (P880090/S010)Bausch & Lomb, Inc.1995-05-22
MEDTRONIC SYNCHROMED INFUSION SYSTEM (P860004/S034)Medtronic, Inc.1995-05-22
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S047)Cordis Corp.1995-05-22
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S046)Cordis Corp.1995-05-22
UVAR PHOTOPHORESIS SYSTEM (P860003/S024)Therakos Development Limited1995-05-18
GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) 12MM LONG (P910030/S003)Cook, Inc.1995-05-17
USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S003)Usci, Div. C.R. Bard, Inc.1995-05-17
ATAKR(TM) RFCA SYSTEM (P930029/S001)Medtronic, Inc.1995-05-17
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S021)Cordis Corp.1995-05-17
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S041)Cordis Corp.1995-05-17
SCIMED POC BANDIT PTCA CATHETER (P860019/S099)Scimed Life Systems, Inc.1995-05-16
E P TECH EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S005)Boston Scientific Corp1995-05-16
MEDTRONIC(R) FALCON(TM) COR. BALL. DIL. CATH. (P870036/S034)Medtronics Interventional Vascular1995-05-16
CHORUS(R) MODEL 6001,3,33 DDD MODEL CPRI MODEL P2A (P900022/S004)MicroPort CRM USA, Inc.1995-05-16
SCIMED POC BANDIT PTCA CATHETER (P860019/S098)Scimed Life Systems, Inc.1995-05-16
SCHNEIDER MICROSOFT(TM) PTCA CATHETERS (P880027/S035)Boston Scientific1995-05-16
MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333 (P890039/S014)Cardiac Control Systems, Inc.1995-05-16
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S010)Spectranetics Corp.1995-05-16
SCIMED(R) LEAP TRIO(TM) PTCA CATHETER (P860019/S097)Scimed Life Systems, Inc.1995-05-16
ENDOTAK(R) LEAD SYSTEM (P910073/S013)Boston Scientific1995-05-16
GELFOAM (N18286/S008)Pfizer, Inc.1995-05-16
ALLERGAN(R) REWETTING DROPS (P910075/S003)Advanced Medical Optics, Inc.1995-05-15
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S023)Cochlear Americas1995-05-15
HYDRASOFT KERATOCONUS METHAFILCON B (P850079/S026)CooperVision, Inc.1995-05-15
ULTRA CARE (TM) NEUTRALIZING TABLET (P850088/S032)Advanced Medical Optics, Inc.1995-05-15
SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT (N12159/S014)ETHICON, Inc.1995-05-12
SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN (P850077/S020)CooperVision, Inc.1995-05-05
REVOLUTIONS (TM) ALT. MANU. SITE CONTACTS (P850077/S018)CooperVision, Inc.1995-05-05
BAUSCH & LOMB RENEW (R) SALINE SOLN. (BL-101-BEU13 (P800024/S017)Bausch & Lomb, Inc.1995-05-05
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S023)Dade Intl., Inc.1995-05-05
HEALON(R) VISCOELASTIC PRODUCTS (P810031/S019)Johnson & Johnson Surgical Vision, Inc.1995-05-03
VENTAK(R) PRX II/III AICD SYSTEM AND IS-1/DF-1 LEADS (P910077/S002)Boston Scientific1995-05-02
UV ABSORBING POST.CHAM.IOL (P810032/S045)Alcon Laboratories1995-05-01
HYBRID CAPTURE(TM) SYSTEM VIRATYPE(R) PLUS HPV DNA (P890064/S003)Qiagen Gaithersburg, Inc.1995-04-28
SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN (P850077/S019)CooperVision, Inc.1995-04-28
WESLEY-JESSEN (R) WJD-1 MULTI-PURPOSE SOLUTION (P910075/S001)Advanced Medical Optics, Inc.1995-04-28
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S020)Cordis Corp.1995-04-27
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S037)Cordis Corp.1995-04-27
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S038)Cordis Corp.1995-04-27
MEDTRONIC ITREL(R) & ITREL(R) SPINAL CORD STIM SYS (P840001/S034)Medtronic Neuromodulation1995-04-27
ENDOTAK(R) LEAD SYSTEM (P910073/S011)Boston Scientific1995-04-27
ROTABLATOR(R) (P900056/S010)Boston Scientific Corp1995-04-27
JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM (P900061/S010)Medtronic Cardiac Rhythm Disease Management1995-04-27
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S036)Cordis Corp.1995-04-27
MEDTRONIC(R) CORONARY BALLOON DILATATION CATHETERS MODELS 18K, 14K SPIRT, EVERGREEN, FALCON AND PANTHER (P870036/S035)Medtronics Interventional Vascular1995-04-27
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S040)Cordis Corp.1995-04-27
MEDTRONIC(R) EVERGREEN 40 CORONARY BALLOON DILATATION CATHETER (P870036/S032)Medtronics Interventional Vascular1995-04-27
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S010)ABBOTT MEDICAL1995-04-27
RELAY/DASH/STRIDE/DART PACING SYSTEMS (P910020/S008)Boston Scientific1995-04-27
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S039)Cordis Corp.1995-04-27
LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT (P890001/S012)Leocor, Inc.1995-04-27
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S047)Allergan1995-04-26
SUPERSTAT (P810040/S007)Superstat Corp.1995-04-21
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S067)Biomerieux Vitek, Inc.1995-04-19
PRECISION(TM) UV (VASURFILCON) (P940013/S004)Alcon Laboratories, Inc.1995-04-19
PROVISC TM VISCOELASTIC PREPARATION (P890047/S005)Alcon Research, Ltd.1995-04-18
VISCOAT(TM) (P840064/S012)Alcon Laboratories1995-04-18
ZYPLAST(R) COLLAGEN IMPLANT (P800022/S035)Allergan1995-04-17
PERMAFLEX NATURALS (SURFILCON A) AND PERMAFLEX UV NATURALS (VASURFILCON A) HYDROPHILIC CONTACT LENSES (P790020/S056)Advanced Medical Optics, Inc.1995-04-17
ENDOTAK(R) SQ LEAD ARRAY MODEL 0048 (P910073/S003)Boston Scientific1995-04-17
VANTAGE (TETRAFILCON A ) CONTACT LENS (N17679/S030)CooperVision, Inc.1995-04-17
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S053)Cochlear Americas1995-04-17
FEMIDOM (P940033)The Female Health Co.1995-04-14
VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB (P830060/S036)Boston Scientific1995-04-13
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S002)Ge Medical Systems, Inc.1995-04-13
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S003)Ge Medical Systems, Inc.1995-04-13
ENDOTAK(R) LEAD SYSTEM (P910073/S008)Boston Scientific1995-04-13
VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB (P830060/S037)Boston Scientific1995-04-13
VENTAK(R) PRX (TM) II AICD SYSTEM (P910077/S006)Boston Scientific1995-04-13
VIGOR SSI PACEMAKER SYSTEM (P840068/S023)Boston Scientific1995-04-13
ENDOTAK(R) LEAD SYSTEM (P910073/S010)Boston Scientific1995-04-13
VASCUTEK GELSEAL(TM) VASCULAR GRAFT (P890045/S005)Carbomedics, Inc.1995-04-13
MODEL MFL 5000 LITHOTRIPTER (P840008/S045)Dornier Medtech America, Inc.1995-04-12
VENTAK(R) P MODEL 1600 (P890061/S009)Boston Scientific1995-04-11
ORTHOGEN/OSTEOGEN IMPLANT. BONE GROWTH STIMULATOR (P790005/S037)Ahp Eos Buyer, Inc.1995-04-06
SPF(R) IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S016)Ahp Eos Buyer, Inc.1995-04-06
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S038)Depuy, Inc.1995-04-05
UV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S (P880091/S002)Staar Surgical Co.1995-04-03
ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 120UV (P880090/S012)Bausch & Lomb, Inc.1995-03-31
FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES (P820021/S026)Alcon Laboratories, Inc.1995-03-31
CHIROFLEX II MODIFIED J LOOP SILICONE INTRA. LENS (P910056/S001)Bausch & Lomb, Inc.1995-03-31
CHIROFLEX(TM) MODEL C10UB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (P910058/S001)Bausch & Lomb, Inc.1995-03-29
ABBOTT AXSYM PSA (LIST 7A49) (P910007/S002)Abbott Laboratories1995-03-29
SYNCHRONY(R) CARDIAC PACING SYSTEM (P880086/S029)ABBOTT MEDICAL1995-03-27
SENSOLOG(R) CARDIAC PACING SYSTEM (P880006/S021)St. Jude Medical, Inc.1995-03-27
ABBOTT AXSYM AFP (LIST 7A48) (P820060/S008)Abbott Laboratories1995-03-27
AFP CARDIAC PACING SYSTEM (P830045/S047)St. Jude Medical, Inc.1995-03-27
ABBOTT AXSYM CEA (LIST 7A47) (P830066/S011)Abbott Laboratories1995-03-27
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S009)Spectranetics Corp.1995-03-24
SCHNEIDER FREEHAND(TM) & MC RAIL PTCA CATHETERS (P880027/S031)Boston Scientific1995-03-24
SCHNEIDER FREEHAND(R) PTCA CATHETERS (P880027/S033)Boston Scientific1995-03-24
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Track 1995 automatically

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