Atlas FDA

1991

481 FDA 510(k) clearances · PMA decision year

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◉ Watch 1991

RecordFirmDate
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S032)Cochlear Americas1991-08-15
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS (P870024/S026)CooperVision, Inc.1991-08-15
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S033)Cochlear Americas1991-08-15
FIBREL (P850053/S004)Mentor Corp.1991-08-14
SOFTLENS(R) (POLYMACON) CONTACT LENSES (N16895/S074)Bausch & Lomb, Inc.1991-08-13
V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES (P780013/S006)Gbf Contact Lenses, Inc.1991-08-13
DORNIER MPL 9000 - MOBILE LITHOTRIPTER (P840008/S028)Dornier Medtech America, Inc.1991-08-13
VENTAK(TM) ECD (P830060/S025)Boston Scientific1991-08-12
SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR (P850035/S012)Ahp Eos Buyer, Inc.1991-08-12
DORNIER MPL 9000 - RENAL APPLICATION (P840008/S026)Dornier Medtech America, Inc.1991-08-12
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S026)Ciba Vision Care1991-08-08
SOFTLENS(R) (POLYMACON) CONTACT LENSES (N16895/S075)Bausch & Lomb, Inc.1991-08-08
RIGID GAS PERMEABLE CONTACT LENSES (P840055/S023)The Lifestyle Co., Inc.1991-08-07
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S010)Medtronic Cardiac Rhythm Disease Management1991-08-07
OPTACRYL 60 - CLEAR (P820056/S048)Paragon Vision Sciences1991-08-07
MODEL 283 PULSE GENERATOR & MODEL 370 PROGRAMMER (P830045/S030)St. Jude Medical, Inc.1991-08-07
DORNIER LITHOTRIPTER MODELS HM3 AND HM4 (P840008/S030)Dornier Medtech America, Inc.1991-08-06
TIER A MODELS 24050,24150,25050,25350-125 LENSES (P880082/S013)Eyetech, LLC1991-08-06
LENS PLUS(R) OXYSEPT(R) 1 DISINFECTING SOLUTION (P850088/S019)Advanced Medical Optics, Inc.1991-08-06
ACS RX ALPHA CORONARY DILATION CATHETERS (P810046/S108)Advanced Cardiovascular Systems, Inc.1991-08-06
LASTAC SYSTEM (P870071/S008)G V Medical, Inc.1991-08-06
HELIX PTCA DILATATION CATHETER (P880003/S005)Cordis Corp.1991-08-06
OPTI-FREE RINSING,DISINFECTING,& STORAGE SOLUTION (P830034/S020)Alcon Laboratories1991-08-06
WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS (P810005/S026)Ciba Vision Care1991-08-06
RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT (P820052/S008)Dupont Legal1991-08-06
RIGID GAS PERMEABLE CONTACT LENSES (P900001/S003)The Lifestyle Co., Inc.1991-08-06
SCHNEIDER XLP(TM) PTCA CATHETER (P880027/S014)Boston Scientific1991-08-06
NEW VUES (TM)(VIFILCON A)(HYDROPHILIC)SOFT LENSES (P820021/S023)Alcon Laboratories, Inc.1991-08-06
AUTIMA PACING SYSTEM (P820018/S050)St. Jude Medical, Inc.1991-07-31
NOVA II MODEL 282-04Y PULSE GENERATOR (P830026/S048)Boston Scientific1991-07-31
ORCOLON (R) (POLYACRYLAMIDE) (P900010/S002)Optical Radiation Corp.1991-07-31
SYNERGYST(TM) II MODELS 7070/7071 (M) (A) (P890003/S006)Medtronic, Inc.1991-07-26
ACTIVITRAX,ATRIVITRAX II, LEGEND, & MICRO MINIX (P850051/S030)Medtronic, Inc.1991-07-26
OMNIFLEX(TM) SOFBLUE(R) HYDROPHILIC CONTACT LENSES (P830047/S006)Advanced Medical Optics, Inc.1991-07-26
GEMNOS (TM) CARDIAC PACEMAKER (P820076/S010)Biotronik, Inc.1991-07-26
SYNCHROMED INFUSION SYSTEM (P860004/S001)Medtronic, Inc.1991-07-25
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S009)Cordis Corp.1991-07-25
DORNIER LITHOTRIPTER MODELS HM3 AND HM4 (P840008/S029)Dornier Medtech America, Inc.1991-07-25
SELF-VENT TO ACS CORONARY DILATATION CATHETER (P810046/S100)Advanced Cardiovascular Systems, Inc.1991-07-25
THREE & SINGLE PIECE BIOCONVEX INTRAOCULAR LENSES (P880082/S009)Eyetech, LLC1991-07-23
SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS (P890040/S003)Unilens Corp., USA1991-07-23
EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES (P880049/S001)Epcon Laboratories1991-07-19
ENZYMUN-TEST{R} AFP (P860044/S002)Boehringer Mannheim Corp.1991-07-19
MICROSS-SL(TM) PTCA DILATATION CATHETER (P880055/S003)Boston Scientific Corp1991-07-19
ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS (P890072/S003)Progressive Chemical Research , Ltd.1991-07-19
NOVALENS (ROSILFOCON A) (P890058/S007)Ocutec Corporation, Inc.1991-07-19
HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS (P890044/S015)Rand Scientific Corp.1991-07-19
FINISHED METHAFILCON A CONTACT LENSES (P890049/S002)Lombart Lenses, Ltd.1991-07-19
O-PERM F60 RGP CONTACT LENS (P890046/S011)Optical Polymer Research, Inc.1991-07-19
CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE (P880079/S010)Ciba Vision Corporation1991-07-15
ALLERGAN(R) PRESERVED SALINE SOL. (0.005% PURITE) (N18020/S036)Advanced Medical Optics, Inc.1991-07-15
HEART TRAK PTCA CATHETER (P840040/S025)Boston Scientific Corp1991-07-12
HEART TRAK PTCA CATHETER (P840040/S024)Boston Scientific Corp1991-07-12
HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS (P890044/S014)Rand Scientific Corp.1991-07-08
POSTERIOR CHAMBER INTRAOCULAR LENSES (P830040/S017)Alcon Research, Ltd.1991-07-03
TIER A LENS MODEL 722D (P810055/S050)Advanced Medical Optics, Inc.1991-07-03
ORCOLON (R) (POLYACRYLAMIDE) (P900010/S001)Optical Radiation Corp.1991-07-03
DORNIER LITHOTRIPTER, MODEL MFL5000 (P840008/S024)Dornier Medtech America, Inc.1991-07-03
DORNIER LITHOTRIPTER, MODEL MFL5000 (P840008/S025)Dornier Medtech America, Inc.1991-07-03
ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS (P890072/S002)Progressive Chemical Research , Ltd.1991-07-02
CMW(TM)2 QUICK SETTING BONE CEMENT (N18466/S012)Depuy, Inc.1991-07-02
INTERTACH(R) II IMPLANT. PACEMAKER PULSE GENERATOR (P860007/S005)Boston Scientific1991-07-02
BAUSCH & LOMB (HEFILCON C) CONTACT LENSES (N17676/S025)Bausch & Lomb, Inc.1991-07-02
ACRYLOC BONE CEMENT (N18466/S013)Depuy, Inc.1991-07-02
FLUOROPERM (PAFLUFOCON A) RGP CONTACT LENS (P870024/S025)CooperVision, Inc.1991-06-28
MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR (P890057/S001)ZOLL Medical Corporation1991-06-27
ACS RX ALPHA(TM).010 CORONARY DILITATION CATHETER (P810046/S098)Advanced Cardiovascular Systems, Inc.1991-06-27
MODEL 405 SPANFLEX TM IOL (P880085)Advanced Medical Optics, Inc.1991-06-27
ACCESS MOBILITY SYSTEM (P900050)Quest Technologies Corp.1991-06-27
PHYSIO-STIM(TM) (P850007/S012)Orthofix, Inc.1991-06-27
SOLUS(TM) MODEL 2002L & SYNCHRONY II MODEL 2022L (P880086/S009)ABBOTT MEDICAL1991-06-26
MEDTRONIC(R) SYNCROMED(R) INFUSION SYSTEM (P860004/S017)Medtronic, Inc.1991-06-26
LASTAC SYSTEM (P870071/S006)G V Medical, Inc.1991-06-25
ACS SPECTRUM(TM) CORONARY DILATATION CATHETER (P810046/S103)Advanced Cardiovascular Systems, Inc.1991-06-25
POLYCON (SILAFOCON A) CONTACT LENSES (N18120/S027)Wesley Jessen Corp.1991-06-24
DYNASOL 4 (P880080/S004)Steridyne Laboratories, Inc.1991-06-20
MODEL PC-36CNB (TIER A) (P820049/S051)Advanced Medical Optics, Inc.1991-06-20
PMS-600 PROGRAMMER (P820076/S012)Biotronik, Inc.1991-06-17
MIRA-FLO STARCH (P900016)Tate & Lyle1991-06-17
WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS (P880076/S001)Dow Corning Wright1991-06-17
SELF-VENT TO ACS CORONARY DILATATION CATHETER (P810046/S099)Advanced Cardiovascular Systems, Inc.1991-06-17
SCHNEIDER MONORAIL PICCOLINO(R) FORTE PTCA CATH. (P880027/S018)Boston Scientific1991-06-13
ALGES(TM) (HEFILCON A) CONTACT LENS (P850002/S006)Unilens Corp., USA1991-06-12
POSTERIOR CHAMBER INTRAOCULAR LENS MODEL C410H (P830056/S070)Carl Zeiss Meditec, AG1991-06-12
LEOCOR CORFLO(TM) MODEL 7.5PT PTCA CATHETER (P890001/S004)Leocor, Inc.1991-06-12
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S004)Abbott Vascular1991-06-12
ZYDERM COLLAGEN IMPLANT (ZYDERM CI) (P800022/S022)Allergan1991-06-07
CMW(TM) RADIOPAQUE BONE CEMENT, HALF PACK (N18466/S011)Depuy, Inc.1991-06-04
O-PERM F60 RGP CONTACT LENS (P890046/S010)Optical Polymer Research, Inc.1991-06-04
MODELS PL70A-OUV, PL70B-OUV, & PL70C-OUV LENSES (P880072/S018)Eyekon Medical, Inc.1991-06-04
AOSEPT(R) & LENSEPT(R) SOLUTIONS (P820040/S027)Ciba Vision Care1991-06-03
MIRAFLOW(R) EXTRA STRENGTH DAILY CLEANER (P850055/S006)Ciba Vision Corporation1991-06-03
PERMAFLEX(R) NATURALS AND PERMAFLEX(R) UV NATURALS (P790020/S053)Advanced Medical Optics, Inc.1991-05-30
HEART TRAK PTCA CATHETER (P840040/S026)Boston Scientific Corp1991-05-30
ACS RX ALPHA(TM) .018 CORONARY DILATATION CATHETER (P810046/S096)Advanced Cardiovascular Systems, Inc.1991-05-30
8IGNATURE CONTACT LENS (P890012/S002)Ciba Vision Corporation1991-05-28
NOVALENS (ROSILFOCON A) (P890058/S009)Ocutec Corporation, Inc.1991-05-28
SOFTHERM SOL. (N18078/S045)Advanced Medical Optics, Inc.1991-05-28
ALLERGAN(R) PRESERVED SALINE SOL. (0.005% PURITE) (N18020/S037)Advanced Medical Optics, Inc.1991-05-28
SOFTMATE SOLUTION (N18073/S020)Advanced Medical Optics, Inc.1991-05-28
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Track 1991 automatically

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