Atlas FDA

1992

343 FDA 510(k) clearances · PMA decision year

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◉ Watch 1992

RecordFirmDate
SYNCHROMED(TM) INFUSION SYSTEM (P860004/S011)Medtronic, Inc.1992-08-12
SYNCHRONY(R) SOFTWARE CHANGE (P880086/S020)ABBOTT MEDICAL1992-08-11
LITHOSTAR CHANGES TO SETTING AND MONITOR (P870018/S006)Siemens Corp.1992-08-11
OPTI-FREE RINSING,DISINFECTING & STORAGE SOLUTION (P830034/S022)Alcon Laboratories1992-08-06
HYDRASOFT (METHAFILCON A) VISIBILITY TINT LENSES (P850079/S020)CooperVision, Inc.1992-08-06
BOSTON LENS II & IV MANU. & DISTRIBUTOR ADDITION (P820065/S079)Polymer Technology Corp.1992-08-06
MODEL 120 POSTERIOR CHAMBER INTRAOCULAR LENS (P860002/S009)Bausch & Lomb1992-08-06
ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC STIMULATORS (P860008/S011)Cardio Command1992-08-06
BOSTON(R) EQUALENS (R) AND RXD (R) MANU./ DIST. (P860022/S041)Bausch & Lomb1992-08-06
MODEL MFL5000 CHANGE TO ELECTRODE PACKAGE INSERT (P840008/S041)Dornier Medtech America, Inc.1992-08-06
CCS MODEL 333 PACEMAKER INTRO. 3 NEW MODELS (P890039/S009)Cardiac Control Systems, Inc.1992-08-03
MEDTRONIC(R) CORONARY BALLOON DILITATION CATHETERS (P870036/S016)Medtronics Interventional Vascular1992-08-03
SLIDER(TM) 018 CORONARY BALLOON SLEEVE MODIFI. (P840040/S031)Boston Scientific Corp1992-07-29
DORNIER MODELS MFL5000 MOBILE LITHOTRIPTER (P840008/S037)Dornier Medtech America, Inc.1992-07-29
ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT (N17755/S040)Zimmer, Inc.1992-07-27
ZYPLAST(R) COLLAGEN IMPLANT (3.0 CC SYRINGE) (P800022/S033)Allergan1992-07-27
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S017)Medstone Intl., Inc.1992-07-27
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S031)G.T. Laboratories, Inc.1992-07-27
EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES (P880049/S002)Epcon Laboratories1992-07-23
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S002)Cordis Corp.1992-07-23
ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS (P890072/S005)Progressive Chemical Research , Ltd.1992-07-22
GELFOAM (N18286/S006)Pfizer, Inc.1992-07-21
ABBOTT IMX-CEA (LIST 3A33) (P830066/S009)Abbott Laboratories1992-07-17
CA 125 ANTIBODY RIA (P850009/S005)Centocor, Inc.1992-07-15
O-PERM F60 RGP CONTACT LENS ADD FINISH LABS (P890046/S017)Optical Polymer Research, Inc.1992-07-14
SLIDER(TM) 018 CORONARY BALLOON DILITATION CATH. (P840040/S030)Boston Scientific Corp1992-07-13
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S016)Medstone Intl., Inc.1992-07-13
HELIX PTCA DILATION CATHETERS AND Y- CONNECTORS (P880003/S009)Cordis Corp.1992-07-13
ACS RX PERFUSION CORON. DILATION CATHETER ADD 2.0 (P810046/S121)Advanced Cardiovascular Systems, Inc.1992-07-10
ACS STACK 40-S(TM) CORONARY DILATATION CATHETER (P810046/S119)Advanced Cardiovascular Systems, Inc.1992-07-10
OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS (P840050/S046)O.S.I. Corp.1992-07-09
MEDTRONIC ITREL II MODELS 7495,7496,7441,7441NC (P840001/S025)Medtronic Neuromodulation1992-07-09
ZYPLAST(R) COLLAGEN IMPLANT (P800022/S032)Allergan1992-07-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT FOR CHILDREN (P890027/S014)Cochlear Americas1992-07-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S041)Cochlear Americas1992-07-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P840024/S042)Cochlear Americas1992-07-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S040)Cochlear Americas1992-07-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P840024/S043)Cochlear Americas1992-07-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT FOR CHILDREN (P890027/S013)Cochlear Americas1992-07-07
ZYPLAST(R) COLLAGEN IMPLANT (P800022/S034)Allergan1992-07-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S011)Cochlear Americas1992-07-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S012)Cochlear Americas1992-07-07
SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS (P890040/S004)Unilens Corp., USA1992-06-29
ADD RGP LENS FINISHING LABORATORIES. (P890044/S021)Rand Scientific Corp.1992-06-26
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S035)G.T. Laboratories, Inc.1992-06-26
COMPACT DISINFECTING UNIT (N16895/S076)Bausch & Lomb, Inc.1992-06-26
ULTRA CARE (TM) NEUTRALIZING TABLET (P850088/S027)Advanced Medical Optics, Inc.1992-06-26
OCUSIL(R) (NEFOCON A) CONTACT LENSES ADD FIN LABS (P840050/S045)O.S.I. Corp.1992-06-26
POSTERIOR CHAMBER INTRAOCULAR LENSES (P870045/S034)Bausch & Lomb, Inc.1992-06-24
CORDIS ORION STEERABLE PTCA CATH. W/GLISSADE HYDRO (P890032/S015)Cordis Corp.1992-06-22
MEDTRONIC(R) 18K(TM) OVER-THE-WIRE CORO.BALL.CATH. (P870036/S015)Medtronics Interventional Vascular1992-06-22
MODEL 3100A FREQUENCY OSCILLATORY VENTILATOR (P890057/S002)ZOLL Medical Corporation1992-06-22
VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (N50510/S046)Biomerieux Vitek, Inc.1992-06-22
TPS 102 PHOTOCEPTOR ACTIVATION CHAMBER (P860003/S021)Therakos Development Limited1992-06-19
TPS 101 PHOTOPHERESIS BLOOD TUBING SET (P860003/S022)Therakos Development Limited1992-06-19
MEDTRONIC(R) MODEL 5342 & 5245 PULSE GENERATOR (P820003/S061)Medtronic Cardiac Rhythm Disease Management1992-06-16
RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS (P910020)Boston Scientific1992-06-15
HELIX PTCA DILATATION CATHETER (P880003/S007)Cordis Corp.1992-06-12
PARAPERM E.W. (PASIFOCON C) RGP GRAY TINT (P850038/S018)Paragon Optical Co.1992-06-12
MODEL 120 POSTERIOR CHAMBER INTRAOCULAR LENS (P860002/S010)Bausch & Lomb1992-06-11
OPTACRYL 60 (KOLFOCON A)RGP BROWN TINT (P820056/S051)Paragon Vision Sciences1992-06-11
PARAPERM O2 (PASIFOCON A) BROWN ,GRAY TINT (P820063/S051)CooperVision, Inc.1992-06-11
O-PERM F60 RGP CONTACT LENS (P890046/S016)Optical Polymer Research, Inc.1992-06-10
MEDTRONIC(R) MODELS 5342 & 5345 TEMP. PULSE GEN. (P820003/S063)Medtronic Cardiac Rhythm Disease Management1992-06-09
IOL LENS MODEL MC40CM (P810032/S042)Alcon Laboratories1992-05-29
IOL LENS MODEL GR1A (P840060/S018)Alcon Laboratories1992-05-29
LAPEL MICROPHONE MODIFICATION (P890027/S008)Cochlear Americas1992-05-29
NITECH TM 018 PTCA CATHETER (P840040/S028)Boston Scientific Corp1992-05-29
MODELS 1S & 1P (P800049/S004)Alcon1992-05-29
POSTERIOR CHAMBER INTRAOCULAR LENSES (P810018/S030)Alcon Laboratories1992-05-29
MODELS KR2V, SK21V, S2BV (P840033/S002)Alcon Laboratories1992-05-29
GAS PERMEABLE COMFORTCARE(TM)WETTING/SOAKING SOLUT (P820053/S020)Advanced Medical Optics, Inc.1992-05-21
RGP DAILY CLEANING TABLET (P880053/S007)Advanced Medical Optics, Inc.1992-05-21
VH8500 HYPERTHERMIA TREATMENT SYSTEM (P880078/S008)Cook, Inc.1992-05-21
LAPEL MICROPHONE/MINI SPEECH PROCESSER (P840024/S037)Cochlear Americas1992-05-21
VH8500 HYPERTHERMIA TREATMENT SYSTEM (P880078/S007)Cook, Inc.1992-05-21
HYBRITECH(R) STRATUS(R) PSA ASSAY FLOUROMETRIC (P850048/S007)Beckman Coulter, Inc.1992-05-21
MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR (P870015/S015)Medstone Intl., Inc.1992-05-19
MODIFIED LABELING FOR IOL 60 MOS.STERILITY EXPIR. (P880082/S014)Eyetech, LLC1992-05-15
VENTAK P MODEL 1600 (P890061/S003)Boston Scientific1992-05-14
VENTAK MODELS 1550 AND 1555 (P830060/S030)Boston Scientific1992-05-14
ULTRA CARE (TM) DISINFECTION SYSTEM (P850088/S025)Advanced Medical Optics, Inc.1992-05-05
ELITE & PRELUDE DR PULSE GENERATORS (P890003/S015)Medtronic, Inc.1992-05-04
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S034)G.T. Laboratories, Inc.1992-05-04
GELFOAM (N18286/S005)Pfizer, Inc.1992-04-30
FLUORO-CEP (R) PROGESTERONE (P900025/S001)Zeus Scientific, Inc.1992-04-21
TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S003)Smiths Industries Medical Systems, Inc.1992-04-21
TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER (P890024/S004)Smiths Industries Medical Systems, Inc.1992-04-21
FLUORO-CEP{R} ESTROGEN ASSAY REAGENT (P860015/S001)Zeus Technologies1992-04-21
FLUORO-CEP (R) PROGESTERONE (P900025/S002)Zeus Scientific, Inc.1992-04-17
FLUORO-CEP{R} ESTROGEN ASSAY REAGENT (P860015/S002)Zeus Technologies1992-04-17
SOFTACT II (POLYMACON) (P830006/S006)Premier Contact Lens1992-04-15
MODEL 3038 FUNCTION PACK FOR ASP-II 3003 PROGRAMME (P880006/S013)St. Jude Medical, Inc.1992-04-14
RIGID GAS PERMEABLE CONTACT LENSES (P840055/S025)The Lifestyle Co., Inc.1992-04-14
MODEL 3038 FUNCTION PACK FOR APS-II 3003 PROGRAMME (P880086/S015)ABBOTT MEDICAL1992-04-14
MODEL 3038 FUNCTION PACT FOR ASP-II 3003 PROGRAMME (P830045/S037)St. Jude Medical, Inc.1992-04-14
RIGID GAS PERMEABLE CONTACT LENSES (P900001/S005)The Lifestyle Co., Inc.1992-04-14
FLUOREX(TM) RIGID GAS PERMEABLE CONTACT LENS (P880001/S033)G.T. Laboratories, Inc.1992-04-14
ADD RGP LENS FINISHING LABORATORIES. (P890044/S020)Rand Scientific Corp.1992-04-14
POSTERIOR CHAMBER INTRAOCULAR LENSES (P870073/S009)Bausch & Lomb, Inc.1992-04-10
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Every clearance here is in the API, with alerts when new ones post.