Atlas FDA

1983

259 FDA 510(k) clearances · PMA decision year

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◉ Watch 1983

RecordFirmDate
BOSTON LENS(R) LENS - CLEAR (P820065/S001)Polymer Technology Corp.1983-12-23
PARAPERM O2 CONTACT LENS (P820063/S002)CooperVision, Inc.1983-12-23
SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH (P820040/S001)Ciba Vision Care1983-12-23
GENESIS-4 (LIDOFILCON A) (P790020/S015)Advanced Medical Optics, Inc.1983-12-23
OSTEOSTIM(R) (P790005/S025)Ahp Eos Buyer, Inc.1983-12-23
DEKLENE(TM) (P810028/S003)Deknatel, Inc.1983-12-23
MENTOR POLYTEF PASTE FOR INJECTION (N16420/S001)Coloplast Corp.1983-12-20
SOFT CONTACT LENS (N17987/S007)Ciba Vision Corporation1983-12-16
USCI GRUNTZIG DILACA CATHETER (P790017/S007)Medtronic, Ireland1983-12-14
DURASOFT CONTACT LENS (N17852/S011)Wesley Jessen Corp.1983-12-08
LENS PLUS(TM) (P820050/S001)Advanced Medical Optics, Inc.1983-12-08
LENS PLUS(TM) (P820050/S002)Advanced Medical Optics, Inc.1983-12-08
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S001)Telectronics Pacing Systems, Inc.1983-12-06
UNISOL (P790011/S009)Wesley Jessen Corp.1983-12-05
PLASMA SEPARATION SYSTEM (P820032/S001)Fenwal, Inc.1983-12-05
SOFLENS (N16895/S028)Bausch & Lomb, Inc.1983-12-05
SAUFLON(R) PW (LIDOFILCON B) (P790020/S010)Advanced Medical Optics, Inc.1983-12-05
BSD 1000 HYPERTHERMIA SYSTEM (P820088)Pyrexar Medical, Inc.1983-11-28
AUTOBAC MTS PLUS TEST SYTEM (P810024/S001)Warner-Lambert Co.1983-11-25
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S007)Analytical Products, Inc.1983-11-25
PDS(TM) SUTURE (CLEAR) (N18387/S010)ETHICON, Inc.1983-11-23
PDS SUTURE (DYED) (N18331/S014)ETHICON, Inc.1983-11-23
PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P (P820023/S004)Pacesetter Systems1983-11-21
OSTEOSTIM(R) (P790005/S024)Ahp Eos Buyer, Inc.1983-11-17
API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM (P800029/S008)Analytical Products, Inc.1983-11-17
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S004)Medtronic Cardiac Rhythm Disease Management1983-11-17
CATGUT SUTURE (N8536/S019)ETHICON, Inc.1983-11-17
EASY EYES (TM) (P830009/S002)Eaton Medical Corp.1983-11-17
OPUS - III CONTACT LENSES (P820074/S001)Wesley Jessen Corp.1983-11-17
ABSORBABLE SURGICAL SUTURE, USP (N10389/S020)ETHICON, Inc.1983-11-17
ABSORBABLE SURGICAL SUTURE, USP (N10389/S021)ETHICON, Inc.1983-11-17
CATGUT SUTURE (N8536/S020)ETHICON, Inc.1983-11-17
MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S005)C.R. Bard, Inc.1983-11-17
MICROFIBRILLAR COLLAGEN HEMOSTAT (N17600/S008)Davol Inc., Sub. C. R. Bard, Inc.1983-11-17
SAUFLON(R) PW (LIDOFILCON B) (P790020/S017)Advanced Medical Optics, Inc.1983-11-17
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S005)Medtronic Cardiac Rhythm Disease Management1983-11-17
DEKLENE(TM) (P810028/S002)Deknatel, Inc.1983-11-17
ETHILON/NUROLON NYLON SUTURES (N85316/S010)ETHICON, Inc.1983-11-14
AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG (P800035/S008)Curasan AG1983-11-10
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007)Telectronics Pacing Systems, Inc.1983-11-10
COLLASTAT (P810006/S003)Integra LifeSciences Corporation1983-11-09
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S004)Dow Corning Corp. Healthcare Industries Materials1983-11-09
HYDRO MARC LENSES (HYDROPHILIC) (N18033/S007)Vistakon, Johnson & Johnson Vision Products, Inc.1983-11-07
MERSILENE*POLYESTER SUTURE (N12815/S017)ETHICON, Inc.1983-11-03
MIC ANTIBIOTIC TEST PANELS (N50494/S006)Pasco Laboratories, Inc.1983-11-02
HEALON (P810031/S001)Johnson & Johnson Surgical Vision, Inc.1983-11-01
SOFTMARK (P820027/S001)Ciba Vision Corporation1983-11-01
SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S007)Dow Corning Corp. Healthcare Industries Materials1983-11-01
OSTEOSTIM(R) (P790005/S022)Ahp Eos Buyer, Inc.1983-10-26
OSTEO CERAMIC HIP (P810048/S003)Smith & Nephew, Inc.1983-10-26
SOFT CONTACT LENS (N17987/S009)Ciba Vision Corporation1983-10-25
LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER (P820009)Bausch & Lomb1983-10-25
CABCURVE (POROFOCAN B) (N18032/S006)Wesley Jessen Corp.1983-10-25
CEA-ROCHE TEST KIT (P800063/S004)Hoffmann-La Roche, Inc.1983-10-18
AUTOBAC MIC TEST SYSTEM (N50524/S014)Organon Teknika Corp.1983-10-18
CLERZ LUBRICATING & REWETTING EYE DROPS (P800034/S003)Alcon Laboratories1983-10-18
AMVISC(R) (P810025)Bausch & Lomb, Inc.1983-10-18
OSTEOSTIM(R) (P790005/S021)Ahp Eos Buyer, Inc.1983-10-14
MIC PANELS (N62160/S010)American Micro Scan1983-10-12
PLASMA SEPARATION SYSTEM (P820032)Fenwal, Inc.1983-10-07
ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM (N50525/S007)Abbott Laboratories1983-10-06
HYDROCURVE (N17752/S015)Ciba Vision Corporation1983-10-03
SOFT MATE COMFORT DROPS (P800018/S004)Advanced Medical Optics, Inc.1983-10-03
SOFTHERM SOL. (N18078/S009)Advanced Medical Optics, Inc.1983-10-03
SOFTMATE SOL. (N18073/S004)Advanced Medical Optics, Inc.1983-10-03
BIO OSTEOGEN SYSTEM 204 (P790002/S004)Ahp Eos Buyer, Inc.1983-10-03
SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP (N11397/S023)ETHICON, Inc.1983-09-28
ETHILON/NUROLON NYLON SUTURES (N85316/S009)ETHICON, Inc.1983-09-28
MIC PANELS (N62160/S009)American Micro Scan1983-09-28
MERSILENE*POLYESTER SUTURE (N12815/S018)ETHICON, Inc.1983-09-28
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S005)Telectronics Pacing Systems, Inc.1983-09-23
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S002)Pacesetter Systems1983-09-20
SOFTCON(R) (VIFILCONA) (P820021/S001)Alcon Laboratories, Inc.1983-09-16
DANKER SILICONE LENS (DIMEFOCON-A) (P790010/S002)Ciba Vision Corporation1983-09-15
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S007)Medtronic Cardiac Rhythm Disease Management1983-09-13
SLEEP SENTRY(TM) (P810044/S001)Diabetes Sentry Products, LLC1983-09-13
UNISOL (P790011/S008)Wesley Jessen Corp.1983-09-13
PERMALENS EXTENDED WEAR CONTACT LENS (P780010/S012)CooperVision, Inc.1983-09-12
SAUFLON(R) PW (LIDOFILCON B) (P790020/S012)Advanced Medical Optics, Inc.1983-09-08
ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER (P820060/S001)Abbott Laboratories1983-08-31
RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT (P820052)Dupont Legal1983-08-31
MIRASOL(TM) (P810008/S004)Wesley Jessen Corp.1983-08-26
BAUSCH & LOMB STERILE PRESERVED SALINE SOLN (P800024/S007)Bausch & Lomb, Inc.1983-08-24
PREFLEX AND FLEXCARE SOL. (N18143/S019)Alcon Laboratories1983-08-24
BOIL N SOAK CONTACT LENS FLUID (N17908/S034)Alcon Laboratories1983-08-24
ADAPETTES (N17945/S016)Alcon Laboratories1983-08-24
SENSITIVE EYES(TM) SALINE SOLUTION (P810039/S004)Bausch & Lomb, Inc.1983-08-24
FLEXSOL (N17974/S030)Alcon Laboratories1983-08-24
CHROMIC GUT STERILE ABSORBABLE SUTURES (N83433/S018)Davis & Geck, Inc.1983-08-18
ZYDERM COLLAGEN IMPLANT (ZYDERM CI) (P800022/S005)Allergan1983-08-18
BAUSCH & LOMB STERILE PRESERVED SALINE SOLN (P800024/S006)Bausch & Lomb, Inc.1983-08-12
MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS (P800038/S002)Marlin Industries1983-08-12
SOFTCON(R) (VIFILCONA) (P820021/S002)Alcon Laboratories, Inc.1983-08-12
MIC PANELS (N62160/S008)American Micro Scan1983-08-10
SOFLENS(R) ENZYMATIC CONTACT LENS CLEANER (N17654/S006)Advanced Medical Optics, Inc.1983-08-10
PROGRAMALITH(TM) MODEL 223 PULSE GENERATOR & 398 P (P820023/S003)Pacesetter Systems1983-08-10
BIOSTATOR GCIIS (P790028/S002)Bayer Healthcare1983-08-08
SOFT MATE WEEKLY CLEANING SOLUTION (P810017/S002)Advanced Medical Optics, Inc.1983-08-05
SOFT MATE COMFORT DROPS (P800018/S003)Advanced Medical Optics, Inc.1983-08-04
SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES (P790029/S002)Advanced Medical Optics, Inc.1983-08-04
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Track 1983 automatically

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