Atlas FDA

1986

536 FDA 510(k) clearances · PMA decision year

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◉ Watch 1986

RecordFirmDate
TESLACON(TM) NMR IMAGING SYSTEM (P830051/S012)Technicare Corp.1986-11-05
CHAMBER LENS MODELS 101, 101B, 101T (P790027/S022)Bausch & Lomb1986-11-03
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S016)Coherent Medical Division1986-10-31
MEDTRONIC{R} CAP SURE{TM} MODEL 4003/4503 PACING (P830061/S002)Medtronic Cardiac Rhythm Disease Management1986-10-31
INTRAOCULAR LENS (P860002)Bausch & Lomb1986-10-31
LC-65 DAILY CONTACT LENS CLEANER (P790024/S008)Advanced Medical Optics, Inc.1986-10-31
BJORK-SHILEY CARDIAC VALVE (P780008/S013)Shiley, Inc.1986-10-31
AB-CORE K HEPATITIS B CORE ANTIGEN 125I (P850044/S002)Sorin Biomedica, Fiat, USA, Inc.1986-10-31
USCI{R} SLIDEWIRE{TM} STEERABLE GUIDE WIRES (P790017/S012)Medtronic, Ireland1986-10-31
SUTURES (N85143/S001)Sharpoint, Inc.1986-10-27
SOFTMATE SOLUTION (N18073/S009)Advanced Medical Optics, Inc.1986-10-27
SOFT-CARE DISINFECTION REGIMEN FOR CONTACT LENSES (P790029/S012)Advanced Medical Optics, Inc.1986-10-27
SOFT MATE COMFORT DROPS (P800018/S007)Advanced Medical Optics, Inc.1986-10-27
SOFT MATE WEEKLY CLEANING SOLUTION (P810017/S008)Advanced Medical Optics, Inc.1986-10-27
3-SOLUTION DISINFECTION REGIMEN (P790001/S006)Advanced Medical Optics, Inc.1986-10-27
NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI (P840024/S003)Cochlear Americas1986-10-24
MICROFIBRILLAR COLLAGEN HEMOSTAT (N17600/S009)Davol Inc., Sub. C. R. Bard, Inc.1986-10-24
FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S003)Fonar Corp.1986-10-22
TESLACON(TM) NMR IMAGING SYSTEM (P830051/S013)Technicare Corp.1986-10-22
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S026)Telectronics Pacing Systems, Inc.1986-10-20
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S017)Telectronics Pacing Systems, Inc.1986-10-20
OPTI-CLEAN(TM) LC 1323 (P820036/S005)Alcon Laboratories1986-10-16
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S012)Coherent Medical Division1986-10-16
GARREN GASTRIC BUBBLE (P840025/S008)American Edwards Laboratories1986-10-16
SOFT MATE(R) PREMIXED PROTEIN REMOVER SOLUTION (P810017/S003)Advanced Medical Optics, Inc.1986-10-16
SOFTHERM SOL. (N18078/S027)Advanced Medical Optics, Inc.1986-10-15
HYDRO MARC LENSES (HYDROPHILIC) (N18033/S014)Vistakon, Johnson & Johnson Vision Products, Inc.1986-10-15
MODEL AC10 & AC20 IOLS (P810056/S003)Advanced Medical Optics, Inc.1986-10-15
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S013)Coherent Medical Division1986-10-15
MODELS PC10 & PC21 (P820049/S010)Advanced Medical Optics, Inc.1986-10-15
BONECEMENT (N17755/S033)Zimmer, Inc.1986-10-14
SOFTHERM SOL. (N18078/S026)Advanced Medical Optics, Inc.1986-10-14
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S026)St. Jude Medical, Inc.1986-10-10
FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S005)Fonar Corp.1986-10-08
FONAR NMR WHOLE BODY SCANNER BETA 3000 (P830076/S004)Fonar Corp.1986-10-08
ORTHOPAK(R) BONE GROWTH STIMULATOR (P850022/S001)Ahp Eos Buyer, Inc.1986-10-08
MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525 (P850089/S003)Medtronic Cardiac Rhythm Disease Management1986-10-07
PLUS XX AND PROFILE PLUS (P790017/S008)Medtronic, Ireland1986-10-07
POSTERIOR CHAMBER INTRAOCULAR LENSES (P810018/S021)Alcon Laboratories1986-10-07
POSTERIOR CHAMBER INTRAOCULAR LENSES (P810018/S020)Alcon Laboratories1986-10-06
SOFTHERM SOL. (N18078/S022)Advanced Medical Optics, Inc.1986-10-03
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S004)Boston Scientific1986-10-03
OPTACRYL 60 - CLEAR (P820056/S020)Paragon Vision Sciences1986-10-01
TESLACON(TM) NMR IMAGING SYSTEM (P830051/S009)Technicare Corp.1986-10-01
TESLACON(TM) NMR IMAGING SYSTEM (P830051/S007)Technicare Corp.1986-10-01
GAS PERMEABLE REGIMEN (P820053/S002)Advanced Medical Optics, Inc.1986-10-01
OCUSIL(TM) CONTACT LENS (P840050/S008)O.S.I. Corp.1986-10-01
TESLACON(TM) NMR IMAGING SYSTEM (P830051/S010)Technicare Corp.1986-10-01
TELECTRONICS PASAR MODEL 4171 PG (P850027)Telectronics, Inc.1986-09-30
CDS II (SODIUM CHONDROITIN SULFATE) (P820079)Alcon Laboratories1986-09-30
NON-ABSORBABLE (POLYESTER FIBER) SUTURES (N83509/S008)Davis & Geck, Inc.1986-09-30
NON-ABSORBABLE SUTURES NYLON (N83511/S006)Davis & Geck, Inc.1986-09-30
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S007)Dornier Medtech America, Inc.1986-09-30
SILK NONABSORBABLE SUTURES, USP (N84047/S011)Davis & Geck, Inc.1986-09-30
KONTUR SOFT (METHAFILCON A) LENS (P850078/S002)Kontur Kontact Lens Co., Inc.1986-09-29
SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS (P850077/S002)CooperVision, Inc.1986-09-29
MODEL AC (AC1-AC5) (P810001/S005)Alcon1986-09-29
OCU-FLEX (P820051/S003)Ocu-Ease Optical Products, Inc.1986-09-29
BOSTON LENS(R) LENS - CLEAR (P820065/S036)Polymer Technology Corp.1986-09-29
AMS CEFOTETAN CARD (N50510/S025)Biomerieux Vitek, Inc.1986-09-29
SM-1, CR-1, & GR-1 IOLS (P840060/S002)Alcon Laboratories1986-09-29
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S014)Carl Zeiss Meditec, AG1986-09-29
POSTERIOR CHAMBER INTRAOCULAR LENSES (P810018/S018)Alcon Laboratories1986-09-29
STYLE 17 & 17A POSTERIOR CHAMBER IOLS (P830033/S005)Advanced Vision Science1986-09-26
CHAMBER LENS MODELS 101, 101B, 101T (P790027/S023)Bausch & Lomb1986-09-26
STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING (P830061/S001)Medtronic Cardiac Rhythm Disease Management1986-09-25
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S011)Coherent Medical Division1986-09-25
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S003)Boston Scientific1986-09-25
SAUFLON(R) PW (LIDOFILCON B) (P790020/S031)Advanced Medical Optics, Inc.1986-09-25
MODEL 5525 TRANSVENOUS ATRAIL & MODEL 5025 VENTRIC (P850089/S002)Medtronic Cardiac Rhythm Disease Management1986-09-25
TESLACON(TM) NMR IMAGING SYSTEM (P830051/S006)Technicare Corp.1986-09-24
MODELS PC10 & PC21 (P820049/S008)Advanced Medical Optics, Inc.1986-09-24
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S004)Hybritech, Inc.1986-09-23
BSD 1000 HYPERTHERMIA SYSTEM (P820088/S005)Pyrexar Medical, Inc.1986-09-23
CRYSTALENS SALINE SPRAY (P850065/S002)Stericon, Inc.1986-09-23
HELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE (P850010/S003)Integra LifeSciences Corporation1986-09-22
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S007)Philips Medical Systems (Cleveland), Inc.1986-09-22
HYDRASOFT (METHAFILCON A) CONTACT LENS (P850079/S004)CooperVision, Inc.1986-09-22
LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER (P820009/S003)Bausch & Lomb1986-09-18
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S001)Datascope Corp.1986-09-18
TRESOFT SOFT CONTACT LENSE (N17855/S005)Ciba Vision Care1986-09-15
SCOLITRON(TM) STIMULATOR (P820008/S003)Ebi, L.P.1986-09-12
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S005)Medtronic, Inc.1986-09-10
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S006)Medtronic, Inc.1986-09-10
AME BONE GROWTH STIMULATOR (P850007/S001)Orthofix, Inc.1986-09-10
COSMOS(TM) SYSTEM (P830026/S016)Boston Scientific1986-09-10
NON-PRESERVED SALINE SOLUTION (P850025/S001)Paco Pharmaceutical Services, Inc.1986-09-09
MAGNETOM (P830081/S004)Siemens Corp.1986-09-08
CEA-ROCHE(R) EIA (P840027/S001)Roche Diagnostics GmbH1986-09-08
ACTIVITRAX MODELS 8400, 8402, 8403 (P850051/S004)Medtronic, Inc.1986-09-04
TANDEM(R)-E AFP (P840035/S004)Beckman Coulter, Inc.1986-09-02
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S006)Pacesetter Systems1986-09-02
SM-1, CR-1, & GR-1 IOLS (P840060/S001)Alcon Laboratories1986-08-29
DUROMEDICS BILEAFLET HEART VALVE (P850006)Edwards Lifesciences, LLC1986-08-29
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S012)Carl Zeiss Meditec, AG1986-08-28
COSMOS(TM) SYSTEM (P830026/S017)Boston Scientific1986-08-28
COSMOS(TM) SYSTEM (P830026/S015)Boston Scientific1986-08-28
COSMOS(TM) SYSTEM (P830026/S018)Boston Scientific1986-08-28
STYLE UV40 POSTERIOR CHAMBER LENS (P830056/S013)Carl Zeiss Meditec, AG1986-08-28
AQUASEPT II (N17679/S012)CooperVision, Inc.1986-08-27
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Track 1986 automatically

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