Atlas FDA

1993

366 FDA 510(k) clearances · PMA decision year

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◉ Watch 1993

RecordFirmDate
TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S005)Smiths Industries Medical Systems, Inc.1993-12-27
B&L RENU ENZYMATIC CLEANING TABLET (P850093/S010)Bausch & Lomb, Inc.1993-12-22
PERMAFLEX(R) NATURALS AND PERMAFLEX(R) UV NATURALS (P790020/S054)Advanced Medical Optics, Inc.1993-12-22
CAPSURE(R) AND CAPSURE(R) SP PACING LEADS (P830061/S019)Medtronic Cardiac Rhythm Disease Management1993-12-21
COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE (P810006/S018)Integra LifeSciences Corporation1993-12-21
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S002)Corcym S.r.l.1993-12-21
ULTRA CARE (TM) NEUTRALIZING TABLET (P850088/S029)Advanced Medical Optics, Inc.1993-12-15
ALTRAZYME PROTEIN CLEANER (P860061/S006)Advanced Medical Optics, Inc.1993-12-15
VENTAK MODEL 6910 LEAD ADAPTOR (P830060/S033)Boston Scientific1993-12-14
VENTAK P MODEL 6910 (P890061/S006)Boston Scientific1993-12-14
COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE (P900039/S003)Neucoll, Inc.1993-12-09
MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015)Medtronic, Inc.1993-12-09
PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED (N18331/S023)ETHICON, Inc.1993-12-09
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS MODEL 250 (P790007/S012)Medtronic Heart Valves1993-12-08
POLYTEF PASTE FOR VOCAL CORD INJECTION (N16420/S004)Coloplast Corp.1993-12-08
GEMNOS(TM)04A CARDIAC PACEMAKER & SWM 600/C00U02 (P820076/S015)Biotronik, Inc.1993-12-08
MEDTRONIC INTREL & INTREL II SPINAL CORD STIM. SYS (P840001/S029)Medtronic Neuromodulation1993-12-07
SCHNEIDER FREEHAND(TM) MODELS FH20-20,25,30,35,40 (P880027/S029)Boston Scientific1993-12-07
UVAR PHOTOPHERESIS SYSTEM (P860003/S020)Therakos Development Limited1993-12-07
VASCUTEK GELSOFT(TM) VASCULAR GRAFT (P890045/S003)Carbomedics, Inc.1993-12-07
ROTABLATOR(R) (P900056/S005)Boston Scientific Corp1993-12-07
PHYSIO-STIM(R) (P850007/S010)Orthofix, Inc.1993-12-06
CAPSURE(R) AND CAPSURE(R)SP LEADS (P850089/S027)Medtronic Cardiac Rhythm Disease Management1993-12-06
OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION (P830034/S023)Alcon Laboratories1993-12-02
POLYMACON CONTACT LENSES (P820059/S020)Wesley Jessen Corp.1993-11-23
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S006)Abiomed Cardiovascular, Inc.1993-11-23
POLYMACON CONTACT LENSES (P780007/S039)CooperVision, Inc.1993-11-23
CIBATINT(TM) TINTING PROCESS (P820086/S011)Ciba Vision Care1993-11-23
\YDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES (P910029/S002)Les Laboratories Blonchard1993-11-23
EXCIMER LASER (P900032/S020)Spectranetics Corp.1993-11-23
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S005)Abiomed Cardiovascular, Inc.1993-11-23
VANTAGE (TETRAFILCON A ) CONTACT LENS (N17679/S027)CooperVision, Inc.1993-11-23
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S040)G.T. Laboratories, Inc.1993-11-23
FLUOROPERM 151 (PAFLUFOCON D) CLEAR & TINTS W/O UV (P870024/S036)CooperVision, Inc.1993-11-23
MODEL 3091B IOL /W 5.0 MM OPTICS (P790027/S056)Bausch & Lomb1993-11-17
INTERPORE PRO OSTEAN(R)IMPLANT 500 COR. HYDROX (P860005/S002)Interpore Intl.1993-11-17
UNILENS (HEFILCON A) CONTACT LENS (P850002/S008)Unilens Corp., USA1993-11-17
UV POSTERIOR CHAMBER INTRAOCULAR LENSES (P870045/S029)Bausch & Lomb, Inc.1993-11-17
SIMULVUE (HEFILCON A) BIFOCAL CONTACT LENS (P850002/S009)Unilens Corp., USA1993-11-17
SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR (P850035/S010)Ahp Eos Buyer, Inc.1993-11-15
SCIMED(R) SC COBRA(TM) 14 PTCA CATHETER (P860019/S071)Scimed Life Systems, Inc.1993-11-08
RX ELIPSE(TM) .014 CORONARY DILITATION CATHETER (P810046/S146)Advanced Cardiovascular Systems, Inc.1993-11-08
MEDTRONIC ELITE II MODEL 7086 (P890003/S021)Medtronic, Inc.1993-11-08
MEDTRONIC(R)PANTHER(TM) CORONARY BALL. DILI. CATH. (P870036/S027)Medtronics Interventional Vascular1993-11-05
O-PERM F60 RGP CONTACT LENS (P890046/S024)Optical Polymer Research, Inc.1993-11-04
MEDTRONIC(R) RAIDER(TM) CORONARY BALL. DILI. CATH. (P870036/S026)Medtronics Interventional Vascular1993-11-04
VISTAKON (ETAFILICON A) HYDROPHILIC CONTACT LENS (N18033/S026)Vistakon, Johnson & Johnson Vision Products, Inc.1993-11-04
SOFT MATE(TM)CONCEPT CLEANING & DISINFECTING SOLUT (P840066/S031)Advanced Medical Optics, Inc.1993-11-04
COLLASTAT HEMO SPONGE CHANGE IN PACKAGING (P810006/S016)Integra LifeSciences Corporation1993-11-01
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S041)Allergan1993-11-01
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S040)Allergan1993-11-01
ZYPLAST(R) AND ZYDERM(R) COLLAGEN IMPLANT (P800022/S044)Allergan1993-11-01
ACUVUE(R) (ETAFILICON A) HYDROPHILIC CONTACT LENS (N18033/S024)Vistakon, Johnson & Johnson Vision Products, Inc.1993-10-27
HFV STAR (P880013/S003)Nellcor Puritan Bennett, Inc.1993-10-26
EXCIMER LASER MODEL DYMER (R) 200+ (P900032/S015)Spectranetics Corp.1993-10-25
HYBRID (PTCA) CATHETER (P850021/S024)Abbott Vascular, Inc.1993-10-25
TIER A & B INTRAOCULAR LENSES (P890068/S001)Chiron Ophthalmics1993-10-22
PTCA BALLOON DILITATION CATHETERS (P840040/S038)Boston Scientific Corp1993-10-21
ACS RX ELIPSE(TM) .014 CORONARY DILITATION CATH. (P810046/S140)Advanced Cardiovascular Systems, Inc.1993-10-21
EXCIMER LASER (LASER CATHETER-MODEL PC4030(2.0MM)) (P900032/S003)Spectranetics Corp.1993-10-19
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S001)Spectranetics Corp.1993-10-18
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S014)W. L. Gore & Associates, Inc.1993-10-15
SATURN II(TM) (SYNERGICON A) CONTACT LENS (P840004/S007)Wesley Jessen Corp.1993-10-14
ACS SPACTRUM(TM) CORONARY DILATATION CATHETER (P810046/S145)Advanced Cardiovascular Systems, Inc.1993-10-13
SURGICEL*/SURGICEL NU-KNIT* ABSORBABLE HEMOSTAT (N12159/S012)ETHICON, Inc.1993-10-13
POLYMACON CONTACT LENSES (P820059/S019)Wesley Jessen Corp.1993-09-30
CHANGES TO ACS(R) SLALOM ADD 1.5 MM BALLOON SIZE (P810046/S124)Advanced Cardiovascular Systems, Inc.1993-09-30
CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT (P900030)Allergan, Inc.1993-09-30
O-PERM F60 RGP CONTACT LENS (P890046/S023)Optical Polymer Research, Inc.1993-09-30
ZYPLAST(R) AND ZYDERM(R)COL.IMP./QUAL.CON.CHANGE (P800022/S039)Allergan1993-09-30
SYSTEM 3 WETTING IN EYE COMFORT DROPS (P870029/S007)Advanced Medical Optics, Inc.1993-09-29
AVITENE(R) MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) (N17600/S011)Davol Inc., Sub. C. R. Bard, Inc.1993-09-29
FALOPE RING BAND AND APPLICATOR SYSTEMS (P870076)Gyrus Acmi, Inc.1993-09-29
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060)Corcym S.r.l.1993-09-29
RESOLVE/GP(TM) DAILY CLEANER (P870026/S005)Advanced Medical Optics, Inc.1993-09-28
LOW PRESSURE BIOPROSTHESIS (MODELS 6625LP & 6625) (P870077/S001)Edwards Lifesciences, LLC1993-09-24
COOK BIRD'S NEST VENA CAVA FILTER (P850049/S003)Cook, Inc.1993-09-23
SCHNEIDER FREEHAND (TM) PTCA CATHETER (P880027/S027)Boston Scientific1993-09-23
CORDIS OLYMPIX,SLEEK, & PREDATOR PTCA CATHETERS (P880003/S016)Cordis Corp.1993-09-23
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S002)Spectranetics Corp.1993-09-23
SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC + (P810002/S026)ABBOTT MEDICAL1993-09-23
O-PERM F60 RGP CONTACT LENS (P890046/S021)Optical Polymer Research, Inc.1993-09-20
O-PERM F60 RGP CONTACT LENS ADD FINISH LABS (P890046/S020)Optical Polymer Research, Inc.1993-09-20
O-PERM F60 RGP CONTACT LENS (P890046/S022)Optical Polymer Research, Inc.1993-09-20
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S039)G.T. Laboratories, Inc.1993-09-15
ACS RX ELIPSE & ELIPSE II CORO.DIL. CATHETERS (P810046/S127)Advanced Cardiovascular Systems, Inc.1993-09-14
SCIMED(R) ACE(TM) 1CM TIP PTCA CATHETER (P860019/S073)Scimed Life Systems, Inc.1993-09-13
MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR (P890034/S001)Covidien1993-09-10
BOSTON LENS II & IV (P820065/S080)Polymer Technology Corp.1993-09-07
BOSTON EQUALENS(R) AND BOSTON RXD(R) (P860022/S043)Bausch & Lomb1993-09-07
BOSTON LENS II & IV (P820065/S081)Polymer Technology Corp.1993-09-07
BOSTON EQUALENS(R) AND BOSTON RXD(R) (P860022/S044)Bausch & Lomb1993-09-07
ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS (P890072/S009)Progressive Chemical Research , Ltd.1993-09-07
SCIMED(R) LONG RALLY (TM) PTCA CATHETER (P860019/S069)Scimed Life Systems, Inc.1993-09-03
NOVALENS (ROSILFOCON A) (P890058/S010)Ocutec Corporation, Inc.1993-09-02
ACS CORONARY DILATATION CATHETERS (P810046/S142)Advanced Cardiovascular Systems, Inc.1993-09-02
SIEMENS PACESETTER MODEL 3070 (P830045/S045)St. Jude Medical, Inc.1993-09-02
GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) (P910030/S001)Cook, Inc.1993-08-30
MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER (P870036/S021)Medtronics Interventional Vascular1993-08-27
CCS MODEL 325 PACEMAKER SYSTEM (P890039/S011)Cardiac Control Systems, Inc.1993-08-26
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Track 1993 automatically

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