Atlas FDA

1991

481 FDA 510(k) clearances · PMA decision year

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◉ Watch 1991

RecordFirmDate
SOFT MATE COMFORT DROPS (P800018/S015)Advanced Medical Optics, Inc.1991-05-28
MODELS PCUB-32D0 AND PCUB-53D0 (P830033/S023)Advanced Vision Science1991-05-28
MODEL SAL2UB (P870045/S017)Bausch & Lomb, Inc.1991-05-28
SOFT MATE(R) CONSEPT R-2 NEUTRALIZING & RINSING (P840066/S024)Advanced Medical Optics, Inc.1991-05-28
SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES (P790029/S020)Advanced Medical Optics, Inc.1991-05-28
SOFT MATE WEEKLY CLEANING SOLUTION (P810017/S018)Advanced Medical Optics, Inc.1991-05-28
GAS PERMEABLE REGIMEN (P820053/S016)Advanced Medical Optics, Inc.1991-05-28
OPTI-FREE RINSING, DISINFECTING & STORAGE SOLUTION (P830034/S013)Alcon Laboratories1991-05-22
SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER (P880027/S016)Boston Scientific1991-05-21
SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER (P880027/S015)Boston Scientific1991-05-21
HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML (P860047/S002)Bausch & Lomb, Inc.1991-05-21
O-PERM F60 RGP CONTACT LENS (P890046/S009)Optical Polymer Research, Inc.1991-05-17
VENTAK 1550 PULSE GENERATOR (P830060/S014)Boston Scientific1991-05-17
MODEL 446 & 447 VISTA T PU.GEN. MODEL 2046 SOF.MOD (P840068/S012)Boston Scientific1991-05-17
HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS (P890044/S013)Rand Scientific Corp.1991-05-17
NOVA II MODEL 282-04Y PULSE GENERATOR (P830026/S046)Boston Scientific1991-05-16
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S031)Cochlear Americas1991-05-16
NUCLES 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHIL (P890027/S002)Cochlear Americas1991-05-16
MODEL 6837 & 6839 INDUCTION/MONITOR & 6871 O-RINGS (P830060/S024)Boston Scientific1991-05-16
NOVA II MODEL 282-04R PULSE GENERATOR (P830026/S045)Boston Scientific1991-05-16
SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER (P880027/S012)Boston Scientific1991-05-16
ARZCO OCTAPOLAR ESOPHAGEAL PACE & RECORD CATHETER (P860008/S010)Cardio Command1991-05-09
VERSATRAX(TM) CARDIAC PACING SYSTEM (P820003/S053)Medtronic Cardiac Rhythm Disease Management1991-05-08
ACTIVITRAX PACING SYSTEM (P850051/S031)Medtronic, Inc.1991-05-08
VERSATRAX,SYMBIOS, & SYNERGYST MODELS (P820003/S058)Medtronic Cardiac Rhythm Disease Management1991-05-08
RIGID GAS PERMEABLE CONTACT LENSES (P840055/S022)The Lifestyle Co., Inc.1991-05-06
SGP II - F CONTACT LENS (P900001/S002)The Lifestyle Co., Inc.1991-05-06
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S010)ABBOTT MEDICAL1991-05-02
VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500 (P880078/S002)Cook, Inc.1991-05-02
VENTAK P 1600 AICD AND 2830 SOFTWARE MODULE (P890061)Boston Scientific1991-05-02
COOK BIRD'S NEST VENA CAVA FILTER (P850049/S002)Cook, Inc.1991-05-02
INTRAOCULAR LENSES (P880082/S011)Eyetech, LLC1991-05-01
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S010)Cordis Corp.1991-04-26
HYDRASOFT (METHAFILCON B) VISIBILITY TINT LENSES (P850079/S018)CooperVision, Inc.1991-04-25
MAESTRO(R) MODEL 1006P PACEMAKER PROGRAMMER (P890039/S002)Cardiac Control Systems, Inc.1991-04-25
MAESTRO(R) MODEL 1006P PACEMAKER PROGRAMMER (P860027/S008)Cardiac Control Systems, Inc.1991-04-25
ACS RX ALPHA .014 QUARTER SIZE BALLOON CATHETER (P810046/S101)Advanced Cardiovascular Systems, Inc.1991-04-25
OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI (P890031/S003)Ocular Technologies, Inc.1991-04-25
SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS (P890040/S002)Unilens Corp., USA1991-04-24
SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS (P840006/S005)Salvatori Ophthalmics Mfg. Corp.1991-04-24
MEDTRONIC ELITE(TM) MODELS 7074,7075,7076,& 7077 (P890003/S003)Medtronic, Inc.1991-04-24
PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052)Smiths Medical Asd, Inc.1991-04-22
THE INTREPID(TM) PTCA CATHETER (P850021/S013)Abbott Vascular, Inc.1991-04-22
O-PERM F60 RGP CONTACT LENS (P890046/S008)Optical Polymer Research, Inc.1991-04-22
TITRATOR{TM} MODEL 10K (P860035/S003)Ivac Corporation1991-04-18
USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM (P890048)Usci, Div. C.R. Bard, Inc.1991-04-17
BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS (P860022/S031)Bausch & Lomb1991-04-16
GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS. (P890063/S002)Matria Healthcare, Inc.1991-04-10
HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS (P890044/S011)Rand Scientific Corp.1991-04-05
LASAG MICRORUPTOR III Q-SWITCH ND:YAG (P840012/S007)Meridian AG1991-04-05
BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS (P860022/S034)Bausch & Lomb1991-04-05
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS (P820065/S075)Polymer Technology Corp.1991-04-05
SCIMED PTCA DILATATION CATHETER (P860019/S035)Scimed Life Systems, Inc.1991-04-05
SCHNEIDER MICROSOFTRAC/MONORAIL PICCOLINO (P880027/S011)Boston Scientific1991-04-03
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S009)Abbott Vascular1991-04-03
SCIMED PTCA DILATATION CATHETER-ACE ADVANTAGE(TM) (P860019/S039)Scimed Life Systems, Inc.1991-04-03
MEDTRONIC MODEL 7441NC CORDIS/ ITREL II ADAPTOR (P840001/S023)Medtronic Neuromodulation1991-04-03
NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM (P830055/S016)Depuy, Inc.1991-04-02
9751A SYSTEM ENHANCEMENT MODULE (SEM) (P820003/S056)Medtronic Cardiac Rhythm Disease Management1991-04-02
PROSTHESIS, HIP, HEMI-FEMORAL, METAL (P820024/S015)Depuy, Inc.1991-04-02
NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI (P840024/S014)Cochlear Americas1991-03-29
MODEL 3100 FREQUENCY OSCILLATORY VENTILATOR (P890057)ZOLL Medical Corporation1991-03-29
~[24~R DIRECT CURRENT BONE GROWTH STIMULATOR (P790008/S005)Zimmer, Inc.1991-03-29
MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU (P840051/S004)Davis & Geck, Inc.1991-03-29
COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS (P810057/S009)CooperVision, Inc.1991-03-28
BSD 1000 HYPERTHERMIA SYSTEM (P820088/S008)Pyrexar Medical, Inc.1991-03-28
MICROSS-SL(TM) PTCA DILATATION CATHETER (P880055/S002)Boston Scientific Corp1991-03-28
CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S002)Incstar Corp.1991-03-28
CA 125 ANTIBODY RIA (P850009/S004)Centocor, Inc.1991-03-28
META DDD MODEL 1230 PACER (P820018/S039)St. Jude Medical, Inc.1991-03-26
SCHNEIDER MONORAIL PICCOLINO(R) PTCA CATHETER (P880027/S013)Boston Scientific1991-03-26
CORDIS ORION EXTENSION (P890032/S008)Cordis Corp.1991-03-26
ESOPHAGEAL CARDIAC RECORDING & PACING CATHETER (P860008/S009)Cardio Command1991-03-25
ULTRAZYME PROTEIN CLEANER (P860061/S005)Advanced Medical Optics, Inc.1991-03-25
INSTAT COLLAGEN ABSORBABLE HEMOSTAT (P830079/S008)ETHICON, Inc.1991-03-22
LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET (P850088/S021)Advanced Medical Optics, Inc.1991-03-21
BOSTON(R) RXD(TM) & ENVISION(TM) RGP CONTACT LENS (P860022/S033)Bausch & Lomb1991-03-21
CIBA VISION CLEANER (P890062/S003)Ciba Vision Corporation1991-03-21
WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS (P810005/S025)Ciba Vision Care1991-03-21
BOSTON LENS II & IV (ITAFOCON A & B) CONTACT LENS (P820065/S074)Polymer Technology Corp.1991-03-21
NOVALENS (ROSILFOCON A) (P890058/S008)Ocutec Corporation, Inc.1991-03-21
CAPSURE(R)SP PACING LEADS (P830061/S015)Medtronic Cardiac Rhythm Disease Management1991-03-20
BUSHINDER OMNIFLEX OVER-THE-WIRE BALLOON CATHETER (P870036/S011)Medtronics Interventional Vascular1991-03-20
MODEL 721A ULTRAVIOLET LIGHT-ABSORBING LENS (POST) (P810055/S042)Advanced Medical Optics, Inc.1991-03-20
SCIMED PTCA DILATATION CATHETER (P860019/S031)Scimed Life Systems, Inc.1991-03-20
MODELS 150A 150SE ULTRA VOILET-ABSORB. POSTERIOR (P810055/S047)Advanced Medical Optics, Inc.1991-03-20
MODEL SP17UB UV POSTERIOR CHAMBER INTRAOCULAR LENS (P870045/S023)Bausch & Lomb, Inc.1991-03-20
PURE-DENT (R) (P890070/S001)Grain Processing Corp.1991-03-20
ACS PINKERTON .018(TM)CORONARY DILATATION CATHETER (P810046/S097)Advanced Cardiovascular Systems, Inc.1991-03-20
ACS(R) STACK PERFUSION(R) CORONARY DILATATION CATH (P810046/S095)Advanced Cardiovascular Systems, Inc.1991-03-20
VISCOAT(TM) (P840064/S009)Alcon Laboratories1991-03-19
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S006)Abbott Vascular1991-03-19
MIRAFLOW(R) EXTRA STRENGTH DAILY CLEANER (P850055/S009)Ciba Vision Corporation1991-03-18
HYDROPERM (TM) RIGID GAS PERMEABLE CONTACT LENS (P890044/S012)Rand Scientific Corp.1991-03-18
LITHOSTAR (P870018/S004)Siemens Corp.1991-03-18
SGP II - F CONTACT LENS (P900001/S001)The Lifestyle Co., Inc.1991-03-18
FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS (P880001/S028)G.T. Laboratories, Inc.1991-03-18
SENSITIVE EYES CHEMICAL DISINFECTANT (P840020/S003)Bausch & Lomb, Inc.1991-03-14
USCI GRUNTZIG DILACA CATHETER (P790017/S022)Medtronic, Ireland1991-03-14
AURORA MODELS 6291 AND 6292 PACEMAKERS (P820018/S048)St. Jude Medical, Inc.1991-03-14
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Track 1991 automatically

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