Atlas FDA

1991

481 FDA 510(k) clearances · PMA decision year

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◉ Watch 1991

RecordFirmDate
LEOCOR PICOCATH(TM) MODEL PICO-ST (P890001/S006)Leocor, Inc.1991-10-25
AUTIMA MODEL 2251 GENERATOR & MODEL 2600 PROGRAMME (P820018/S052)St. Jude Medical, Inc.1991-10-25
MODELS 8416 AND 8418 LEGEND PACEMAKERS (P850051/S033)Medtronic, Inc.1991-10-25
REFLEX MODEL 8223E DUAL CHAMBER PULSE GENERATOR (P820018/S051)St. Jude Medical, Inc.1991-10-25
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS (P870024/S027)CooperVision, Inc.1991-10-23
HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS (P890044/S017)Rand Scientific Corp.1991-10-23
HYDRASOFT (METHAFILCON A) VISIBILITY TINT LENSES (P850079/S019)CooperVision, Inc.1991-10-23
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S005)Davis & Geck, Inc.1991-10-17
3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV (P830040/S023)Alcon Research, Ltd.1991-10-17
PERIOCHECK TM ENZYME ACTIVITY TEST KIT (P870059/S001)Actech Advanced Clinical Technologies, Inc.1991-10-16
INTERTACH & INTERTACH II PULSE GENERATORS (P860007/S007)Boston Scientific1991-10-16
META II MODEL 1204 CARDIAC PACING SYSTEM (P880038/S013)St. Jude Medical, Inc.1991-10-11
MODEL UP675 POSTERIOR CHAMBER INTRAOCULAR LENS (P860059/S051)Advanced Medical Optics, Inc.1991-10-09
MODEL UPB350S POSTERIOR CHAMBER INTRAOCULAR LENS (P860059/S059)Advanced Medical Optics, Inc.1991-10-09
LAMICEL(R) OSSMOTIC CERVICAL DILATOR (P820075/S005)Medtronic Xomed, Inc.1991-10-09
MODEL UP350 - POSTERIOR CHAMBER INTRAOCULAR LENS (P860059/S053)Advanced Medical Optics, Inc.1991-10-09
MODEL 56BUV20-24DO IOL (P830033/S024)Advanced Vision Science1991-10-07
HELIX PTCA DILATATION CATHETER (P880003/S006)Cordis Corp.1991-10-04
HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR (P850023/S011)Datascope Corp.1991-10-04
MEDTRONIC(R) 18K(TM) OVER THE WIRE BALL. CATHETER (P870036/S012)Medtronics Interventional Vascular1991-10-04
DURASOFT CONTACT LENSES /SHELF LIFE (N17852/S033)Wesley Jessen Corp.1991-10-04
MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM (P890039/S005)Cardiac Control Systems, Inc.1991-10-04
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S011)Cordis Corp.1991-10-04
MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM (P890039/S004)Cardiac Control Systems, Inc.1991-10-04
DORNIER MPL9000 LITHOTRIPTER (P840008/S033)Dornier Medtech America, Inc.1991-10-04
DURASOFT R3 (PHEMFILCON A) LENSES/SHELF LIFE (P830037/S032)Alcon Laboratories, Inc.1991-10-04
ZYDERM COLLAGEN IMPLANT (ZYDERM CI) (P800022/S025)Allergan1991-09-30
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S018)ABBOTT MEDICAL1991-09-30
STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES (P870038)Edwards Lifesciences, LLC1991-09-27
PALMAZ BALLOON EXPANDABLE STENT (P890017)Cordis US Corporation1991-09-27
9751B SYSTEM ENHANCEMENT MODULE PRINTER (P820003/S059)Medtronic Cardiac Rhythm Disease Management1991-09-27
PROVISC(TM)VISCOELASTIC PREPARATION (P890047)Alcon Research, Ltd.1991-09-26
EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES (P860057)Edwards Lifesciences, LLC1991-09-26
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS (P870077)Edwards Lifesciences, LLC1991-09-25
CARPENTIER-EDWARDS BIOPROSTHESES MODELS 2625&6625 (P870056)Edwards Lifesciences, LLC1991-09-25
AXSYM TOTAL PSA & ARCHITECT TOTAL PSA (P910007)Abbott Laboratories1991-09-25
MODEL 8810 SYNCHROMED PROGRAMMER (P860004/S019)Medtronic, Inc.1991-09-24
NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM (P830055/S018)Depuy, Inc.1991-09-23
POSTERIOR CHAMBER INTRAOCULAR LENSES STYLE 38XE (P830040/S018)Alcon Research, Ltd.1991-09-23
VOL. HYPERTHERMIA TREATMENT SYSTEM MODAL VH8500 (P880078/S001)Cook, Inc.1991-09-20
HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS (P890044/S016)Rand Scientific Corp.1991-09-19
N.C.G.T. GRAFT (P800058/S011)St. Jude Medical, Inc.1991-09-19
ELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM (P900048)Staar Surgical Co.1991-09-17
COLLASTAT (P810006/S013)Integra LifeSciences Corporation1991-09-17
ETI-HA-IGMK (P890014/S001)DiaSorin, Inc.1991-09-16
SENSOLOG 2020T, SESOLOG II 2022T, SOLUS 200T (P880086/S014)ABBOTT MEDICAL1991-09-16
APS-11 MODEL 3003 PROGRAMMER (P880086/S011)ABBOTT MEDICAL1991-09-16
APS-II MODEL 3003 PROGRAMMER (P880006/S010)St. Jude Medical, Inc.1991-09-16
ELASTIC UVA PC IOL. (P880091)Staar Surgical Co.1991-09-16
APS-II MODEL 3003 PROGRAMMER (P830045/S033)St. Jude Medical, Inc.1991-09-16
AMERICAN EDWARDS LABS HYBRID PTCA CATHETER (P850021/S014)Abbott Vascular, Inc.1991-09-16
O-PERM F60 RGP CONTACT LENS (P890046/S012)Optical Polymer Research, Inc.1991-09-13
VANTAGE & VANTAGE THIN (TETRAFILCON A) CONTACT LEN (N17679/S025)CooperVision, Inc.1991-09-13
NEWLENSCO CLASSIC SERIES(TM) MODEL MP-2410 TIER B (P870075/S003)Newlensco1991-09-13
PACESETTER MODEL 3070 & PACE MEDICAL MODEL 4553 (P830045/S031)St. Jude Medical, Inc.1991-09-11
HYDRON HYDROPHILIC CONTACT LENS (P780007/S036)CooperVision, Inc.1991-09-10
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S030)Cochlear Americas1991-09-10
H55 HYDROPHILIC CONTACT LENS (P890023/S001)The Cooper Companies1991-09-10
P.C.A.(TM) TOTAL KNEE SYSTEM (P840049/S001)Howmedica Corp.1991-09-10
NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL (P890027/S001)Cochlear Americas1991-09-10
RICHARD WOLF PIEZOLITH E.L.P. LITHOTRIPT MODEL2300 (P890013)Richard Wolf Medical Instruments Corp.1991-09-09
POLYCON CONTACT LENS (N18120/S024)Wesley Jessen Corp.1991-09-06
CHORUS DDD PACEMAKER (P900022)MicroPort CRM USA, Inc.1991-09-06
TIER A - LENS MODEL SP18UB (P870045/S025)Bausch & Lomb, Inc.1991-09-05
TIER A MODELS 24050,24150,25050,25350-125 LENSES (P880082/S012)Eyetech, LLC1991-09-04
ACS RX ALPHA CORONARY DILATION CATHETERS (P810046/S109)Advanced Cardiovascular Systems, Inc.1991-09-04
ENZYMUN-TEST{R} AFP (P860044/S003)Boehringer Mannheim Corp.1991-09-03
SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B (P880006/S008)St. Jude Medical, Inc.1991-09-03
ACE(TM) AND LONG ACE(TM) MODELS (P860019/S043)Scimed Life Systems, Inc.1991-08-29
SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (P860040/S010)Wavetouch Technologies, LLC1991-08-29
FLEXLENS (HEFILCON A) SOFT CONTACT LENSES (P900058/S001)Westcon Contact Lens Co., Inc.1991-08-29
BIOPOLYMERIC(TM) VASCULAR GRAFT (P800058/S014)St. Jude Medical, Inc.1991-08-29
VANTAGE & VANTAGE THIN (TETRAFILCON A) CONTACT LEN (N17679/S024)CooperVision, Inc.1991-08-29
MEDTRONIC MODEL 7441NC CORDIS/ ITREL II ADAPTOR (P840001/S024)Medtronic Neuromodulation1991-08-29
MODEL AT-103(SIZES 19-31MM) & MT-103(SIZES 19-33MM (P810002/S020)ABBOTT MEDICAL1991-08-29
TECHNICON-38 (POLYMACON) HYDROPHYLIC LENSES (P900065/S001)Westcon Contact Lens Co., Inc.1991-08-29
ALGES(TM) (HEFILCON A) CONTACT LENS (P850002/S007)Unilens Corp., USA1991-08-28
VALIDATION/GETINGE ETHYLENE OXIDE STERILIZER (P880070/S003)Abbott Medical Optics, Inc.1991-08-27
GETINGE ETHYLENE OXIDE STERILIZER (P810055/S052)Advanced Medical Optics, Inc.1991-08-27
VALIDATION/GETINGE ETHYLENE OXIDE STERILIZER (P880041/S002)Abbott Medical Optics, Inc.1991-08-27
SCIMED(R) PTCA CATHETER (P860019/S041)Scimed Life Systems, Inc.1991-08-27
REVOLUTION(TM) (METHAFILCON A) HYDROPHILIC LENS (P850077/S015)CooperVision, Inc.1991-08-27
SIMPSON CORONARY ATHEROCATH(TM) SCA-LP(TM) DEVICE (P890043/S011)Abbott Vascular1991-08-27
TIER A - LENS MODEL CM11UB (P870045/S027)Bausch & Lomb, Inc.1991-08-22
TIER B - LENS MODEL SP24UB (P870045/S026)Bausch & Lomb, Inc.1991-08-22
STERILIZED FINISHED OCUFILCON B LENSES (P820051/S009)Ocu-Ease Optical Products, Inc.1991-08-22
MODEL 5603 PROGRAMMER SOFTWARE, VP.11P. (P820018/S049)St. Jude Medical, Inc.1991-08-21
FLUOREX(TM) FLUSILFOCON) 700,500,300 RGP LENS (P880001/S030)G.T. Laboratories, Inc.1991-08-21
MODEL 1210 OMNIPULSE(TM) HOLMIUM LASER SYSTEM (P870043/S013)Trimedyne, Inc.1991-08-20
PRENTIF TM CAVITY RIM CERVICAL CAP (P870062/S002)Lamberts Dalston , Ltd.1991-08-20
SOLUS 2002,2003 & SYNCHRONY II 2022,2023 PULSE GEN (P880086/S013)ABBOTT MEDICAL1991-08-19
CAPSURE(R)SP MODELS 4024/4524 PACING LEADS (P830061/S012)Medtronic Cardiac Rhythm Disease Management1991-08-19
VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT (P880009/S004)Qiagen, Inc.1991-08-19
MODEL 9852 SOFTWARE SYSTEM (P890003/S008)Medtronic, Inc.1991-08-19
NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL (P890027/S004)Cochlear Americas1991-08-15
OPTACRYL 60 - CLEAR (P820056/S049)Paragon Vision Sciences1991-08-15
PARAPERM E.W. (PASIFOCON C) RGP CONTACT LENS (P850038/S016)Paragon Optical Co.1991-08-15
PARAPERM O2 (PASIFOCON A) CONTACT LENS (P820063/S049)CooperVision, Inc.1991-08-15
NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL (P890027/S003)Cochlear Americas1991-08-15
ACS RX(R) ALPHA .O14 CORONARY DILITATION CATHETER (P810046/S105)Advanced Cardiovascular Systems, Inc.1991-08-15
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Track 1991 automatically

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