Atlas FDA

1987

546 FDA 510(k) clearances · PMA decision year

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◉ Watch 1987

RecordFirmDate
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S014)Dornier Medtech America, Inc.1987-12-31
FLUOROPERM RGP CONTACT LENSES (P870024)CooperVision, Inc.1987-12-31
BLAIREX STERILE SALINE SOLUTION (P850045/S006)Blairex Laboratories, Inc.1987-12-30
MODELS PC10 & PC21 (P820049/S020)Advanced Medical Optics, Inc.1987-12-30
MAGNISCAN 5000 MRI SYSTEM (P850043/S001)Thomson-Cgr Medical Corp.1987-12-30
C-65 DAILY CONTACT LENS CLEANER (P790024/S016)Advanced Medical Optics, Inc.1987-12-30
IMPROVED SOACLENS (P830071/S002)Alcon Laboratories1987-12-30
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S017)Ciba Vision Care1987-12-30
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S012)Dornier Medtech America, Inc.1987-12-29
MAGNISCAN 5000 MRI SYSTEM (P850043/S002)Thomson-Cgr Medical Corp.1987-12-29
CLINI-THERM MARK I/IV (P840015/S009)Clini-Therm Corp.1987-12-29
CLINI-THERM MARK I/IV (P840015/S007)Clini-Therm Corp.1987-12-29
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S013)Dornier Medtech America, Inc.1987-12-29
DANKER SILICONE LENS (DIMEFOCON-A) (P790010/S006)Ciba Vision Corporation1987-12-29
MAGNETOM (P830081/S013)Siemens Corp.1987-12-29
STERICON SALINE SOLUTION (P850070/S002)Automatic Liquid Packaging, Inc.1987-12-29
THIMEROSAL PRESERVED SALINE SOLUTION (P850047/S001)Paco Pharmaceutical Services, Inc.1987-12-29
PROSORBA(TM) COLUMN (P850020)Fresenius Hemocare, Inc.1987-12-23
MODELS 019B, 019C, 019E, 019F, 019J, & 019K (P810055/S024)Advanced Medical Optics, Inc.1987-12-22
MAESTRO SERIES 500 P.G. MODELS 501, 505, 509 (P860027/S001)Cardiac Control Systems, Inc.1987-12-22
MODELS PC10 & PC21 (P820049/S024)Advanced Medical Optics, Inc.1987-12-21
CLINI-THERM MARK I/IV (P840015/S005)Clini-Therm Corp.1987-12-18
MODEL AC10 & AC20 IOLS (P810056/S006)Advanced Medical Optics, Inc.1987-12-18
DURASOFT(R) 3 FOR EXT WEAR (P830037/S020)Alcon Laboratories, Inc.1987-12-17
PARAPERM O2 CONTACT LENS (P820063/S022)CooperVision, Inc.1987-12-17
TITRATOR MODEL 10K (P860035)Ivac Corporation1987-12-17
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S030)Biomerieux Vitek, Inc.1987-12-17
AQUAFLEX HYDROPHILIC CONTACT LENSES (N17679/S013)CooperVision, Inc.1987-12-14
DILAPAN(TM) (P840045/S003)Medicem Technology S.R.O1987-12-14
PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN (P850038/S001)Paragon Optical Co.1987-12-14
GORE-TEX(R) EXPANDED PTFE SUTURE (P820083/S006)W. L. Gore & Associates, Inc.1987-12-14
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S008)ABBOTT MEDICAL1987-12-11
ULTRAZYME PROTEIN CLEANER (P860061/S002)Advanced Medical Optics, Inc.1987-12-11
SGP LENS(TM) (P840055/S008)The Lifestyle Co., Inc.1987-12-08
CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC (P820072/S017)Bausch & Lomb, Inc.1987-12-07
MODELS PC10 & PC21 (P820049/S023)Advanced Medical Optics, Inc.1987-12-07
MODEL AC10 & AC20 IOLS (P810056/S005)Advanced Medical Optics, Inc.1987-12-07
CHAMBER LENS MODELS 101, 101B, 101T (P790027/S028)Bausch & Lomb1987-12-07
OCUSIL(TM) CONTACT LENS (P840050/S023)O.S.I. Corp.1987-12-04
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S005)Medtronic Cardiac Rhythm Disease Management1987-12-03
BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S011)ABBOTT MEDICAL1987-12-03
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S020)Coherent Medical Division1987-12-01
BOSTON LENS(R) CONDITIONING SOLUTION (P820070/S011)Polymer Technology Corp.1987-12-01
OCUSIL(TM) CONTACT LENS (P840050/S025)O.S.I. Corp.1987-12-01
BOSTON LENS(R) CONDITIONING SOLUTION (P820070/S012)Polymer Technology Corp.1987-12-01
VISCOAT(TM) (P840064/S006)Alcon Laboratories1987-12-01
HYPO-CARE STERILE SALINE SPRAY (P860033/S001)Bausch & Lomb, Inc.1987-12-01
SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM (P840066/S007)Advanced Medical Optics, Inc.1987-12-01
OCUSIL(TM) CONTACT LENS (P840050/S024)O.S.I. Corp.1987-12-01
KONTUR SOFT (METHAFILCON A) LENS (P850078/S006)Kontur Kontact Lens Co., Inc.1987-12-01
SOFTHERM SOL. (N18078/S033)Advanced Medical Optics, Inc.1987-12-01
SOFTVIEW SPHERICAL & TORIC CONTACT LENS (P830003/S004)Optical Plastic Research1987-12-01
QUASEPT II (N17679/S016)CooperVision, Inc.1987-12-01
DEXON (N16881/S011)Davis & Geck, Inc.1987-11-30
BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS (P860022)Bausch & Lomb1987-11-30
KESTREL NO. 695 HEATER (P820087/S008)Atrion Medical Products, Inc.1987-11-27
ISTAMARC TORIC (ETAFILCONA)) (N18033/S018)Vistakon, Johnson & Johnson Vision Products, Inc.1987-11-25
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012)General Electric Co.1987-11-25
CARIDEX(TM) REMOVAL SYSTEM (P830035/S003)Indevus Pharmaceuticals, Inc.1987-11-25
MODELS PC10 & PC21 (P820049/S022)Advanced Medical Optics, Inc.1987-11-24
MODELS B-13F (P-10) & B-1H (P-11) (P810032/S012)Alcon Laboratories1987-11-24
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S009)Philips Medical Systems (Cleveland), Inc.1987-11-20
THE BLAIREX SYSTEM (P800028/S015)Blairex Laboratories, Inc.1987-11-20
HYPO-CARE STERILE SALINE SPRAY (P860033/S003)Bausch & Lomb, Inc.1987-11-19
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S005)Boston Scientific1987-11-18
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S011)Medtronic, Inc.1987-11-18
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S003)Trimedyne, Inc.1987-11-18
STERIDYNE DYNASPRAY (P860050/S001)Optopics Laboratories Corp.1987-11-17
NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI (P840024/S012)Cochlear Americas1987-11-17
AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS (N50510/S029)Biomerieux Vitek, Inc.1987-11-17
USCI GRUNTZIG DILACA CATHETER (P790017/S015)Medtronic, Ireland1987-11-13
SCIMED PTCA DILATATION CATHETER (P860019/S003)Scimed Life Systems, Inc.1987-11-10
SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM (P840066/S004)Advanced Medical Optics, Inc.1987-11-10
UVAR PHOTOPHERESIS SYSTEM (P860003/S004)Therakos Development Limited1987-11-06
UVAR PHOTOPHERESIS SYSTEM (P860003/S003)Therakos Development Limited1987-11-06
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S010)Philips Medical Systems (Cleveland), Inc.1987-11-05
VISCOAT(TM) (P840064/S005)Alcon Laboratories1987-11-04
SM-1, CR-1, & GR-1 IOLS (P840060/S004)Alcon Laboratories1987-11-03
MODEL AC (AC1-AC5) (P810001/S006)Alcon1987-11-03
OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5) (P820035/S008)Alcon1987-11-03
DURASOFT CONTACT LENS (N17852/S025)Wesley Jessen Corp.1987-11-03
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S034)Medtronic Cardiac Rhythm Disease Management1987-11-02
N.C.G.T. GRAFT (P800058/S007)St. Jude Medical, Inc.1987-11-02
ABBOTT CEA-EIA ONE-STEP (P830066/S004)Abbott Laboratories1987-11-02
OPTACRYL 60 VIOLET CONTACT LENS (P820056/S011)Paragon Vision Sciences1987-11-02
BOSTON LENS(R) LENS - CLEAR (P820065/S049)Polymer Technology Corp.1987-10-30
KESTREL NO. 695 HEATER (P820087/S010)Atrion Medical Products, Inc.1987-10-30
HYDROCURVE (N17752/S030)Ciba Vision Corporation1987-10-27
BOSTON LENS(R) CLEANER (P820069/S010)Polymer Technology Corp.1987-10-27
AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR (P830070/S005)Ciba Vision Corporation1987-10-27
VISCOAT(TM) (P840064/S004)Alcon Laboratories1987-10-27
TINTED TETRAFILCON A CONTACT LENSES (P840071/S001)Ciba Vision Corporation1987-10-27
HORIZON(TM) YAG LASER MODEL 2000 (P850001/S009)CooperVision, Inc.1987-10-27
DURASOFT(R) 3 FOR EXT WEAR (P830037/S021)Alcon Laboratories, Inc.1987-10-27
OCUSIL(TM) CONTACT LENS (P840050/S021)O.S.I. Corp.1987-10-27
OCUSIL(TM) CONTACT LENS (P840050/S022)O.S.I. Corp.1987-10-27
HYPO-CARE STERILE SALINE SPRAY (P860033/S002)Bausch & Lomb, Inc.1987-10-27
QUASEPT II (N17679/S014)CooperVision, Inc.1987-10-27
COSMOS(TM) SYSTEM (P830026/S030)Boston Scientific1987-10-21
BLAIREX STERILE SALINE SOLUTION (P850045/S005)Blairex Laboratories, Inc.1987-10-20
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Track 1987 automatically

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