Atlas FDA

1985

464 FDA 510(k) clearances · PMA decision year

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◉ Watch 1985

RecordFirmDate
SOFTHERM SOL. (N18078/S012)Advanced Medical Optics, Inc.1985-10-22
POLYQUAT DISINFECTION SYSTEM (P830034/S001)Alcon Laboratories1985-10-22
HORIZON(TM) YAG LASER MODEL 2000 (P850001/S001)CooperVision, Inc.1985-10-22
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S013)Telectronics Pacing Systems, Inc.1985-10-21
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S002)General Electric Co.1985-10-18
SOFT CONTACT LENS (N17987/S012)Ciba Vision Corporation1985-10-10
MODELS B-13F (P-10) & B-1H (P-11) (P810032/S006)Alcon Laboratories1985-10-10
OPTACRYL 60 - CLEAR (P820056/S009)Paragon Vision Sciences1985-10-10
HYDROCURVE (N17752/S024)Ciba Vision Corporation1985-10-10
BOSTON LENS(R) LENS - CLEAR (P820065/S023)Polymer Technology Corp.1985-10-10
SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS (P840006/S002)Salvatori Ophthalmics Mfg. Corp.1985-10-10
INSTAT(TM) COLLAGEN ABSORBABLE HEMOSTAT (P830079)ETHICON, Inc.1985-10-10
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S016)Medtronic Cardiac Rhythm Disease Management1985-10-10
BOSTON LENS(R) CONDITIONING SOLUTION (P820070/S007)Polymer Technology Corp.1985-10-10
CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC (P820072/S005)Bausch & Lomb, Inc.1985-10-09
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S010)Abbott Laboratories1985-10-08
PERMATINT(R) (P820059/S007)Wesley Jessen Corp.1985-10-04
HYDRACON(R) CONTACT LENSES (P820017/S008)Hydracon1985-10-04
VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS (P830060)Boston Scientific1985-10-04
HYDRO MARC LENSES (HYDROPHILIC) (N18033/S011)Vistakon, Johnson & Johnson Vision Products, Inc.1985-10-04
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S003)Ciba Vision Care1985-10-04
LENS PLUS(TM) (P820050/S013)Advanced Medical Optics, Inc.1985-10-03
MODELS PC10 & PC21 (P820049/S001)Advanced Medical Optics, Inc.1985-10-03
MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS (P800038/S007)Marlin Industries1985-10-03
PARAPERM O2 CONTACT LENS (P820063/S014)CooperVision, Inc.1985-10-03
HORIZON(TM) YAG LASER MODEL 2000 (P850001/S003)CooperVision, Inc.1985-10-03
LENS PLUS(TM) (P820050/S009)Advanced Medical Optics, Inc.1985-10-01
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S019)St. Jude Medical, Inc.1985-10-01
POSTERIOR CHAMBER INTRAOCULAR LENSES (P810018/S008)Alcon Laboratories1985-10-01
MODEL AC (AC1-AC5) (P810001/S004)Alcon1985-10-01
SOFTMARK (P820027/S002)Ciba Vision Corporation1985-10-01
MODELS 1S & 1P (P800049/S003)Alcon1985-10-01
BSD 1000 HYPERTHERMIA SYSTEM (P820088/S004)Pyrexar Medical, Inc.1985-10-01
INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 (P800036/S007)Intera Oncology1985-09-30
HYSKON (32% DEXTRAN 70) (N17511/S006)Coopervision Surgical1985-09-30
MODELS PC10 & PC21 (P820049/S002)Advanced Medical Optics, Inc.1985-09-30
SOFTSITE (HEFILCON A) CONTACT LENS (N17793/S006)Unilens Corporation, USA1985-09-30
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S009)St. Jude Medical, Inc.1985-09-26
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S007)Medtronic Cardiac Surgery1985-09-24
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S012)Medtronic Cardiac Surgery1985-09-24
LENS PLUS(TM) (P820050/S010)Advanced Medical Optics, Inc.1985-09-20
LENS PLUS(TM) (P820050/S011)Advanced Medical Optics, Inc.1985-09-20
PARAPERM O2 CONTACT LENS (P820063/S007)CooperVision, Inc.1985-09-19
HORIZON(TM) YAG LASER MODEL 2000 (P850001/S002)CooperVision, Inc.1985-09-18
CHROMIC GUT STERILE ABSORBABLE SUTURES (N83433/S019)Davis & Geck, Inc.1985-09-17
PLAIN GUT STERILE ABSORBABLE SUTURES (N83038/S019)Davis & Geck, Inc.1985-09-17
KONTRON CUTANEOUS PCO2 MONITOR (P810037/S004)Kontron Cardiovascular1985-09-12
KONTRON CUTANEOUS PCO2 MONITOR (P810037/S006)Kontron Cardiovascular1985-09-12
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S014)Advanced Cardiovascular Systems, Inc.1985-09-10
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S001)General Electric Co.1985-09-10
BIO-SORB ABSORBABLE DUSTING POWDER (N6264/S003)Johnson & Johnson Medical, Inc.1985-09-10
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S012)Advanced Cardiovascular Systems, Inc.1985-09-10
MLI 1000 ND:YAG OP LASER (P830025/S002)Medical Laser, Inc.1985-09-06
LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER (P820009/S001)Bausch & Lomb1985-09-05
STYLES 30 & 31 POSTERIOR CHAMBER IOLS (P830040)Alcon Research, Ltd.1985-09-05
CHAMBER LENS MODELS 101, 101B, 101T (P790027/S014)Bausch & Lomb1985-09-05
STYLE 17 & 17A POSTERIOR CHAMBER IOLS (P830033)Advanced Vision Science1985-09-05
MODELS 019B, 019C, 019E, 019F, 019J, & 019K (P810055/S008)Advanced Medical Optics, Inc.1985-09-05
OSTEOSTIM(R) (P790005/S026)Ahp Eos Buyer, Inc.1985-09-04
TCO2M MODEL 818 MONITOR (P810022/S009)Novametrix Medical Systems, Inc.1985-09-03
NEW JERSEY LCS(TM) TOTAL KNEE SYSTEM (P830055/S005)Depuy, Inc.1985-08-29
CYBERLITH IV UNIPOLAR PULSE GENERATOR (P800019/S009)Boston Scientific1985-08-29
SENSITIVE EYES(TM) SALINE SOLUTION (P810039/S010)Bausch & Lomb, Inc.1985-08-29
HYDROCURVE (N17752/S022)Ciba Vision Corporation1985-08-28
CARIDEX(TM) REMOVAL SYSTEM (P830035/S002)Indevus Pharmaceuticals, Inc.1985-08-28
NOR-SA-TAB (P800069/S007)Amcon, Inc.1985-08-28
SURGILENE (N17825/S014)Davis & Geck, Inc.1985-08-23
KONTRON CUTANEOUS PCO2 MONITOR (P810037/S005)Kontron Cardiovascular1985-08-22
AMIKACIN ELUTION DISK FOR AUTOBAC (N50485/S014)Organon Teknika Corp.1985-08-22
CENTRAL'S PHARM. SALT TABLETS FOR DISINFECTION (P810030/S001)Central Pharmaceuticals, Inc.1985-08-22
LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE (P820019/S003)Biochem International, Inc.1985-08-21
LENS-WET(TM) (P800065/S004)Advanced Medical Optics, Inc.1985-08-20
BIO OSTEOGEN SYSTEM 204 (P790002/S006)Ahp Eos Buyer, Inc.1985-08-20
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S004)Ciba Vision Care1985-08-20
HYDRACON(R) CONTACT LENSES (P820017/S001)Hydracon1985-08-16
B&L 58(TM) (ETAFILCONA) CONTACT LENS (P850039)Bausch & Lomb, Inc.1985-08-16
CLINI-THERM MARK I/IV (P840015)Clini-Therm Corp.1985-08-16
DANKER SILICONE LENS (DIMEFOCON-A) (P790010/S005)Ciba Vision Corporation1985-08-16
ACCUSEPT DISINFECTING UNIT (N17734/S004)Strieter Laboratories, Inc.1985-08-15
COSMOS(TM) SYSTEM (P830026/S011)Boston Scientific1985-08-14
SOFLENS (N16895/S036)Bausch & Lomb, Inc.1985-08-14
ADAPETTES (N17945/S021)Alcon Laboratories1985-08-13
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S012)Telectronics Pacing Systems, Inc.1985-08-12
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S019)Telectronics Pacing Systems, Inc.1985-08-12
HYDRON HYDROPHILIC CONTACT LENS (P780007/S016)CooperVision, Inc.1985-08-09
CHOYCE MARK VIII ANTERIOR CHAMBER INTEROCULAR LENS (P800017/S002)Storz Ophthalmics, Inc.1985-08-08
TESLACON(TM) NMR IMAGING SYSTEM (P830051/S002)Technicare Corp.1985-08-08
CHAMBER LENS MODELS 101, 101B, 101T (P790027/S013)Bausch & Lomb1985-08-08
CHAMBER LENS MODELS 101, 101B, 101T (P790027/S015)Bausch & Lomb1985-08-08
PHOTOTOME(TM) SYSTEM 2700 (P850019)Laser Media1985-08-08
MODELS 019B, 019C, 019E, 019F, 019J, & 019K (P810055/S016)Advanced Medical Optics, Inc.1985-08-07
OPTI-CLEAN(TM) LC 1323 (P820036/S004)Alcon Laboratories1985-08-06
LENSOAK (P790023/S006)Abbott Medical Optics, Inc.1985-08-06
BOSTON LENS(R) LENS - CLEAR (P820065/S022)Polymer Technology Corp.1985-08-05
COSMOS(TM) SYSTEM (P830026/S010)Boston Scientific1985-08-05
CILCO ND:YAG LASER (P840047)Coopervision-Cilco1985-08-02
NOR-SA-TAB (P800069/S006)Amcon, Inc.1985-07-31
BOSTON LENS(R) CLEANER (P820069/S006)Polymer Technology Corp.1985-07-31
THE SOFT RINSE SYSTEM (P800060/S006)Dow Corning Corp. Healthcare Industries Materials1985-07-30
CIBATINT(TM) TINTING PROCESS (P820086/S004)Ciba Vision Care1985-07-30
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Track 1985 automatically

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