Atlas FDA

1988

640 FDA 510(k) clearances · PMA decision year

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◉ Watch 1988

RecordFirmDate
STRKYER KNEE AUGMENTATION GRAFT (P850054)Meadox Medicals, Div. Boston Scientific Corp.1988-12-30
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S038)Medtronic Cardiac Rhythm Disease Management1988-12-29
UVAR PHOTOPHERESIS SYSTEM (P860003/S006)Therakos Development Limited1988-12-29
FLUOREX (TM) 600 (FLURSILFOCON A) (P880001/S004)G.T. Laboratories, Inc.1988-12-29
AUTOBAC MIC TEST SYSTEM (N50524/S031)Organon Teknika Corp.1988-12-28
IN A WINK CLEANING SOLUTION (P870005/S001)Ciba-Geigy Corp.1988-12-28
MAESTRO SERIES 500 P.G. MODELS 501, 505, 509 (P860027/S002)Cardiac Control Systems, Inc.1988-12-28
UVAR PHOTOPHERESIS SYSTEM (P860003/S010)Therakos Development Limited1988-12-28
SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP (N11397/S027)ETHICON, Inc.1988-12-28
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S049)Advanced Cardiovascular Systems, Inc.1988-12-28
ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7 (P860008/S005)Cardio Command1988-12-27
VIRAPAP HUMAN PAPILLOMAVIRUS DNA DETECTION KIT (P880009)Qiagen, Inc.1988-12-23
SOFLENS (N16895/S054)Bausch & Lomb, Inc.1988-12-23
ETHIBOND* (N17804/S038)ETHICON, Inc.1988-12-22
CATGUT SUTURE (N8536/S024)ETHICON, Inc.1988-12-22
ETHILON/NUROLON NYLON SUTURES (N85316/S016)ETHICON, Inc.1988-12-22
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S039)Biomerieux Vitek, Inc.1988-12-22
MERSILENE*POLYESTER SUTURE (N12815/S023)ETHICON, Inc.1988-12-22
SCIMED PTCA DILATATION CATHETER (P860019/S014)Scimed Life Systems, Inc.1988-12-21
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070/S030)Ciba Vision Corporation1988-12-21
POLYCON CONTACT LENS (N18120/S022)Wesley Jessen Corp.1988-12-21
ALCON ENZYME CLEANER (P820001/S013)Alcon Laboratories1988-12-20
SAUFLON(R) PW (LIDOFILCON B) (P790020/S042)Advanced Medical Optics, Inc.1988-12-16
SOFT CONTACT LENS (N17987/S018)Ciba Vision Corporation1988-12-15
CLINI-THERM MARK I/IV (P840015/S013)Clini-Therm Corp.1988-12-15
SPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S001)Trimedyne, Inc.1988-12-15
BOSTON LENS(R) LENS - CLEAR (P820065/S060)Polymer Technology Corp.1988-12-13
PREFLEX DAILY CLEANING SOLN FOR SENSITIVE EYES (N17974/S042)Alcon Laboratories1988-12-13
ADAPETTES (N17945/S022)Alcon Laboratories1988-12-13
ALVEOFORM TM BIOGRAFT (P860012/S001)Collagen Corp.1988-12-13
OPTI-CLEAN(TM) LC 1323 (P820036/S006)Alcon Laboratories1988-12-13
THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS (P860022/S013)Bausch & Lomb1988-12-13
BSD 1000 HYPERTHERMIA SYSTEM (P820088/S006)Pyrexar Medical, Inc.1988-12-13
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S039)Telectronics Pacing Systems, Inc.1988-12-12
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S039)Medtronic Cardiac Rhythm Disease Management1988-12-12
BOSTON LENS(R) LENS - CLEAR (P820065/S059)Polymer Technology Corp.1988-12-12
MODEL 304 (ULTRA C-LOOP) (P860059/S008)Advanced Medical Optics, Inc.1988-12-12
GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS (P850074/S004)W. L. Gore & Associates, Inc.1988-12-12
THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS (P860022/S004)Bausch & Lomb1988-12-08
DURASOFT(R) 3 FOR EXT WEAR (P830037/S016)Alcon Laboratories, Inc.1988-11-30
DURASOFT CONTACT LENS (N17852/S023)Wesley Jessen Corp.1988-11-30
DURASOFT CONTACT LENS (N17852/S022)Wesley Jessen Corp.1988-11-30
DURASOFT(R) 3 FOR EXT WEAR (P830037/S019)Alcon Laboratories, Inc.1988-11-30
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S013)Medtronic Neuromodulation1988-11-29
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070/S029)Ciba Vision Corporation1988-11-29
GAS PERMEABLE REGIMEN (P820053/S010)Advanced Medical Optics, Inc.1988-11-29
CEA-ROCHE(R) EIA (P840027/S004)Roche Diagnostics GmbH1988-11-29
PARAPERM O2 CONTACT LENS (P820063/S037)CooperVision, Inc.1988-11-28
SOFLENS (N16895/S052)Bausch & Lomb, Inc.1988-11-28
COSMOS(TM) SYSTEM (P830026/S037)Boston Scientific1988-11-23
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S017)Medtronic, Inc.1988-11-23
ZYDERM COLLAGEN IMPLANT (ZYDERM CI) (P800022/S015)Allergan1988-11-22
BAUSCH & LOMB STERILE PRESERVED SALINE SOLN (P800024/S015)Bausch & Lomb, Inc.1988-11-21
LENS-WET(TM) (P800065/S012)Advanced Medical Optics, Inc.1988-11-21
MODELS PC10 & PC21 (P820049/S038)Advanced Medical Optics, Inc.1988-11-21
LENS FRESH(TM) LUBRICATING & REWETTING SOLN (N18020/S026)Advanced Medical Optics, Inc.1988-11-21
MODELS PC10 & PC21 (P820049/S033)Advanced Medical Optics, Inc.1988-11-18
SYNCHROMED(TM) INFUSION SYSTEM (P860004/S003)Medtronic, Inc.1988-11-17
FLUOROPERM RGP CONTACT LENSES (P870024/S003)CooperVision, Inc.1988-11-15
FLUOROPERM RGP CONTACT LENSES (P870024/S004)CooperVision, Inc.1988-11-15
POLYCON CONTACT LENS (N18120/S021)Wesley Jessen Corp.1988-11-15
OCUSIL(TM) CONTACT LENS (P840050/S039)O.S.I. Corp.1988-11-10
METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT (P820026/S004)Metrosoft, Inc.1988-11-10
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070/S028)Ciba Vision Corporation1988-11-10
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S014)Medtronic Neuromodulation1988-11-10
SORBIC ACID PRESERVED DAILY CLEANER (P850076/S006)Paco Pharmaceutical Services, Inc.1988-11-10
FLUOREX (TM) 600 (FLURSILFOCON A) (P880001/S001)G.T. Laboratories, Inc.1988-11-10
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S020)Abbott Laboratories1988-11-10
THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS (P860022/S012)Bausch & Lomb1988-11-08
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S007)Boston Scientific1988-11-08
INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 (P800036/S013)Intera Oncology1988-11-04
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S006)Medtronic Cardiac Rhythm Disease Management1988-11-03
BOSTON LENS(R) LENS - CLEAR (P820065/S054)Polymer Technology Corp.1988-11-03
SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER (N17654/S020)Advanced Medical Optics, Inc.1988-11-01
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S038)Biomerieux Vitek, Inc.1988-11-01
BLAIREX STERILE SALINE SOLUTION (P850045/S013)Blairex Laboratories, Inc.1988-10-28
SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR (P850035/S006)Ahp Eos Buyer, Inc.1988-10-28
SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS (P850077/S008)CooperVision, Inc.1988-10-28
SOFTHERM SOL. (N18078/S040)Advanced Medical Optics, Inc.1988-10-28
SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM (P840066/S015)Advanced Medical Optics, Inc.1988-10-28
B AND L 70 LIDOFILCON A CONTACT LENSE (P880029/S002)Bausch & Lomb, Inc.1988-10-28
ALVEOFORM TM BIOGRAFT (P860012)Collagen Corp.1988-10-28
CORDIS PTCA DILATATION CATHETER (P880003)Cordis Corp.1988-10-28
MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT (P870015/S003)Medstone Intl., Inc.1988-10-26
SENSITIVE EYES CLEANING/DISINFECTING SOLUTION (P860023/S002)Bausch & Lomb, Inc.1988-10-26
THE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS (P860022/S005)Bausch & Lomb1988-10-26
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012/S005)Meridian AG1988-10-26
SCIMED PTCA DILATATION CATHETER (P860019/S015)Scimed Life Systems, Inc.1988-10-24
COSMOS(TM) SYSTEM (P830026/S034)Boston Scientific1988-10-24
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S037)Biomerieux Vitek, Inc.1988-10-24
COSMOS(TM) SYSTEM (P830026/S035)Boston Scientific1988-10-24
COSMOS(TM) SYSTEM (P830026/S036)Boston Scientific1988-10-24
FETAL ACOUSTIC STIMULATOR, MODEL 0146AAY (P870025/S001)Ge Medical Systems, Inc.1988-10-20
SGP LENS(TM) (P840055/S011)The Lifestyle Co., Inc.1988-10-19
WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES (P800011/S008)Ciba Vision Corporation1988-10-19
UNISOL (P790011/S014)Wesley Jessen Corp.1988-10-18
MAESTRO SERIES 500 P.G. MODELS 501, 505, 509 (P860027/S003)Cardiac Control Systems, Inc.1988-10-18
AUTOBAC MIC TEST SYSTEM (N50524/S030)Organon Teknika Corp.1988-10-18
MINI BALLOON (P780011/S011)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-10-18
MODEL 304 (ULTRA C-LOOP) (P860059/S003)Advanced Medical Optics, Inc.1988-10-17
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Track 1988 automatically

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