Atlas FDA

1994

432 FDA 510(k) clearances · PMA decision year

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◉ Watch 1994

RecordFirmDate
SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S004)Howmedica Corp.1994-12-30
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S018)Medstone Intl., Inc.1994-12-22
ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES (P930014)Alcon Laboratories, Inc.1994-12-22
ABSORBABLE COLLAGEN HEMOSTAT (P850023/S014)Datascope Corp.1994-12-22
CA 125 ANTIBODY RIA (P850009/S007)Centocor, Inc.1994-12-21
PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED (N18331/S024)ETHICON, Inc.1994-12-21
SPF(R) IMPLANTABLE SPINAL FUSION STIMULATOR (P850035/S017)Ahp Eos Buyer, Inc.1994-12-21
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S021)Depuy, Inc.1994-12-19
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S065)Biomerieux Vitek, Inc.1994-12-14
OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION (P830034/S025)Alcon Laboratories1994-12-13
PROVISC TM VISCOELASTIC PREPARATION (P890047/S004)Alcon Research, Ltd.1994-12-13
PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO (P800026/S010)Alcon Laboratories1994-12-13
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S019)Cordis Corp.1994-12-13
SOFT MATE SALINE SOLUTION / SENSITIVE EYES (N17908/S046)Alcon Laboratories1994-12-13
COOPERVISION PEROXIDE SYSTEM (P830023/S007)Alcon Laboratories1994-12-13
8LERZ LUBRICATING & REWETTING EYE DROPS (P800034/S015)Alcon Laboratories1994-12-13
PD 1343 DISINFECTING TABLET (P890059/S001)Alcon Laboratories1994-12-13
AFP CARDIAC PACING SYSTEM (P830045/S048)St. Jude Medical, Inc.1994-12-13
ADAPETTES (N17945/S027)Alcon Laboratories1994-12-13
UNISOL PLUS(TM) PH BALANCED SALINE SOLUTION (P790011/S020)Wesley Jessen Corp.1994-12-13
HYBRID (PTCA) CATHETER (P850021/S027)Abbott Vascular, Inc.1994-12-13
ALCON ENZYME CLEANER (P820001/S017)Alcon Laboratories1994-12-13
CAPSURE(R) AND CAPSURE(R)SP LEADS (P850089/S031)Medtronic Cardiac Rhythm Disease Management1994-12-13
PREFLEX (N17974/S047)Alcon Laboratories1994-12-13
SCIMED(R) DYNA-MITE(T)PTCA CATHETER (P860019/S088)Scimed Life Systems, Inc.1994-12-13
FLEX-CARE II (N18143/S032)Alcon Laboratories1994-12-13
OPTI-CLEAN DAILY CLEANER (P820036/S012)Alcon Laboratories1994-12-13
PD1413 WETTING, SOAKING AND DISINFECTING SOLUTION (P830071/S005)Alcon Laboratories1994-12-13
STERILE PRESERVED SALINE SOLUTION (P890067/S004)Steridyne Laboratories, Inc.1994-12-12
MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD (P830061/S024)Medtronic Cardiac Rhythm Disease Management1994-12-12
SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (P860040/S011)Wavetouch Technologies, LLC1994-12-12
CAPSURE(R) AND CAPSURE(R)SP LEADS (P850089/S029)Medtronic Cardiac Rhythm Disease Management1994-12-08
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S022)Dade Intl., Inc.1994-12-08
DELTA(R) PULSE GENERATOR (P840068/S020)Boston Scientific1994-12-08
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S025)Abbott Vascular1994-12-02
MODEL 809A POTERIOR CHAMBER INTRAOCULAR LENS (P810055/S063)Advanced Medical Optics, Inc.1994-12-02
CCS MODEL 325 PACEMAKER SYSTEM (P890039/S012)Cardiac Control Systems, Inc.1994-12-02
PURE-DENT (R) (P890070/S002)Grain Processing Corp.1994-11-30
NEW JERSEY LCS(R) TOTAL KNEE SYSTEM (P830055/S034)Depuy, Inc.1994-11-30
ADATO SIL 5000 (P910071/S001)Bausch & Lomb1994-11-30
ANTERIOR CHAMBER INTRAOCULAR LENSES MODEL 121UV (P880090/S014)Bausch & Lomb, Inc.1994-11-29
MEDTRONIC(R) SYNERGYST II (P890003/S027)Medtronic, Inc.1994-11-29
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011)3M Company1994-11-28
CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT (P900030/S002)Allergan, Inc.1994-11-23
VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB (P830060/S035)Boston Scientific1994-11-23
ENDOTAK(R) LEAD SYSTEM (P910073/S004)Boston Scientific1994-11-23
VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR (P910077/S001)Boston Scientific1994-11-23
LIFE PULSE HIGH FREQUENCY JET VENTILATOR (P850064/S010)Bunnell, Inc.1994-11-18
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S009)Abiomed Cardiovascular, Inc.1994-11-17
SCIMED(R) NC COBRA 18 PTCA CATHETER (P860019/S084)Scimed Life Systems, Inc.1994-11-15
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S007)Spectranetics Corp.1994-11-15
ACS RX FLOWTRACK LONG(TM) CORONARY DILATATION CATH (P810046/S152)Advanced Cardiovascular Systems, Inc.1994-11-14
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S045)Allergan1994-11-14
8IGNATURE CONTACT LENS (P890012/S003)Ciba Vision Corporation1994-11-09
MEDTRONIC(R) 14K(TM)CORONARY BALL DILATATION CATH (P870036/S025)Medtronics Interventional Vascular1994-11-09
HYDROCURVE (N17752/S035)Ciba Vision Corporation1994-11-09
PRECISION(TM) UV (VASURFILCON) (P940013/S002)Alcon Laboratories, Inc.1994-11-09
BAUSCH & LOMB(R) RENU(R) MULTI-PURPOSE SOLUTION (P860023/S008)Bausch & Lomb, Inc.1994-11-07
B&L SENSITIVE EYES(TM) SALINE/CLEANING SOLUTION (P850036/S001)Bausch & Lomb, Inc.1994-11-07
MIGHTY(TM) CORONARY BALLOON DILATATION CATHETERS (P840040/S041)Boston Scientific Corp1994-11-07
ADATOMED SILICONE OIL OP5000 (P910071)Bausch & Lomb1994-11-04
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S066)Biomerieux Vitek, Inc.1994-11-03
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S006)Spectranetics Corp.1994-10-31
BAUSCH & LOMB NATURAL TINT(TM) POLYMACON LENS (N16895/S082)Bausch & Lomb, Inc.1994-10-31
SYNCHRONY(R) CARDIAC PACING SYSTEM (P880086/S026)ABBOTT MEDICAL1994-10-31
EPT-1000 CARDIAC ABLATION SYSTEM (P920047)Boston Scientific Corp1994-10-28
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S003)ABBOTT MEDICAL1994-10-28
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S006)ABBOTT MEDICAL1994-10-28
BIOPOLYMERIC(TM) VASCULAR GRAFT (P800058/S015)St. Jude Medical, Inc.1994-10-25
1 PIECE POSTERIOR CHAMBER IOL (P840039/S044)Bausch & Lomb, Inc.1994-10-25
CORDIS BASIC 18 PTCA DILATATION CATHETER (P880003/S031)Cordis Corp.1994-10-25
VIGOR DDD PACEMAKER SYSTEM (P840068/S021)Boston Scientific1994-10-21
ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II (P920027)C.R. Bard, Inc.1994-10-21
REALITY FEMALE CONDOM (P910064/S003)The Female Health Co.1994-10-18
SCIMED(R) PTCA CATHETER (P860019/S093)Scimed Life Systems, Inc.1994-10-17
MODEL UV65 SERIES ANTERIOR CHAMBER LENSES (P880070/S005)Abbott Medical Optics, Inc.1994-10-17
CARBON TIP CARDIAC PACING LEAD (P800041/S014)Pacesetter Systems1994-10-17
SYNCHROMED MODEL 8703W INTRASPINAL CATHETER (P860004/S030)Medtronic, Inc.1994-10-17
SYNCHRONY MODELS PARAGON III/PHOENIX III PACERS (P880086/S022)ABBOTT MEDICAL1994-10-17
ABBOTT IMX PSA (P910007/S003)Abbott Laboratories1994-10-17
SCIMED(R) TRIO(TM) 14 PTCA CATHETER (P860019/S083)Scimed Life Systems, Inc.1994-10-14
HYDROXYPROPYLMETHYLCELLULOSE 2% OCCUCOAT (R) (P860047/S008)Bausch & Lomb, Inc.1994-10-13
3.4F SYNERGY(TM) II LONG BALL. DILATATION CATHETER (P840040/S043)Boston Scientific Corp1994-10-06
MEDTRONIC SINGLE CHAMBER PACEMAKERS (P850051/S043)Medtronic, Inc.1994-10-06
MEDTRONIC DUAL CHAMBER PACEMAKERS (P890003/S029)Medtronic, Inc.1994-10-06
SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A (P900009)Bioventus, LLC1994-10-05
MODELS PC-43,44,45 NB UV ABSORBING IOL (P820049/S057)Advanced Medical Optics, Inc.1994-10-04
ACCUTECH SINGLE & THREE PIECE INTRAOCULAR LENSES (P880082/S017)Eyetech, LLC1994-10-04
MICROSCAN RAPID FLUOROGENIC PANELS (P870049/S021)Dade Intl., Inc.1994-10-04
COLLAGRAFT(TM) BONE GRAFT MATRIX (P900039/S005)Neucoll, Inc.1994-09-30
ORACLE(TM) CORONARY BALLOON DILATATION CATHETER (P910031)Abbott Vascular Devices1994-09-30
CORDIS EUROPASS PTCA DILATATION CATHETER (P880003/S023)Cordis Corp.1994-09-30
PRECISION(TM) UV (VASURFILCON) (P940013)Alcon Laboratories, Inc.1994-09-30
HEARTMATE VE LVAS (P920014)Thoratec Corp1994-09-30
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S011)Abiomed Cardiovascular, Inc.1994-09-30
2.9F-TO-3.4F ALLY(TM) PTCA CATHETER (P840040/S045)Boston Scientific Corp1994-09-30
OSEPT(R) & LENSEPT(R) SOLUTIONS (P820040/S030)Ciba Vision Care1994-09-30
COOK CHORIONIC VILLUS SAMPLING SET (P900007)Cook Incorporated1994-09-30
CORDIS PREDATOR PTCA DILATATION CATHETER (P880003/S030)Cordis Corp.1994-09-29
CORDIS SLEEK DILATATION CATHETERS (P880003/S029)Cordis Corp.1994-09-29
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Track 1994 automatically

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