Atlas FDA

1986

536 FDA 510(k) clearances · PMA decision year

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◉ Watch 1986

RecordFirmDate
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S003)Dornier Medtech America, Inc.1986-04-14
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S001)Dornier Medtech America, Inc.1986-04-14
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S005)Medtronic Neuromodulation1986-04-14
SOFT CONTACT LENS (N17987/S013)Ciba Vision Corporation1986-04-14
ALCON ENZYME CLEANER (P820001/S008)Alcon Laboratories1986-04-14
CUSTOMEYES(TM) 45L&55L (BUFILCON A) (P850057)Ciba Vision Corporation1986-04-14
POSTERIOR CHAMBER INTRAOCULAR LENSES (P810018/S012)Alcon Laboratories1986-04-11
POSTERIOR CHAMBER INTRAOCULAR LENSES (P810018/S009)Alcon Laboratories1986-04-11
SOFTLENS CLEANING & DISINFECTING SOLN. (N17786/S006)Advanced Medical Optics, Inc.1986-04-09
ENCORE AFP (P840035/S002)Beckman Coulter, Inc.1986-04-08
MODELS PC10 & PC21 (P820049/S004)Advanced Medical Optics, Inc.1986-03-31
AQUASEPT II (N17679/S011)CooperVision, Inc.1986-03-31
CIBATINT(TM) TINTING PROCESS (P820086/S005)Ciba Vision Care1986-03-31
STYLES 31-34 POSTERIOR IOLS (P830056/S001)Carl Zeiss Meditec, AG1986-03-31
SURGICEL (N12159/S006)ETHICON, Inc.1986-03-31
AQUASEPT II (N17679/S010)CooperVision, Inc.1986-03-31
PERMALENS EXTENDED WEAR CONTACT LENS (P780010/S014)CooperVision, Inc.1986-03-31
OPTACRYL 60 - CLEAR (P820056/S012)Paragon Vision Sciences1986-03-31
ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES (P840039)Bausch & Lomb, Inc.1986-03-28
STYLES 31-34 POSTERIOR IOLS (P830056)Carl Zeiss Meditec, AG1986-03-28
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S022)Medtronic Cardiac Rhythm Disease Management1986-03-27
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S020)Advanced Cardiovascular Systems, Inc.1986-03-27
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S025)St. Jude Medical, Inc.1986-03-27
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S025)Medtronic Cardiac Rhythm Disease Management1986-03-27
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S019)Advanced Cardiovascular Systems, Inc.1986-03-27
AUTIMA(TM) MODEL 2251 & MODEL 2600 (P820018/S024)St. Jude Medical, Inc.1986-03-27
AID-B AUTOMATIC IMPLANTABLE CARDIOVERTOR DIFIBRILL (P830060/S001)Boston Scientific1986-03-27
AMMENDMENT TO E. COLI ASC (N50510/S023)Biomerieux Vitek, Inc.1986-03-27
MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS (P840040/S001)Boston Scientific Corp1986-03-25
PLIAGEL CLEANING SOLUTION FOR HYDROPHILIC(SOFT) CO (P800026/S003)Alcon Laboratories1986-03-21
CLERZ LUBRICATING & REWETTING EYE DROPS (P800034/S006)Alcon Laboratories1986-03-21
AUTOBAC MTS PLUS TEST SYTEM (P810024/S003)Warner-Lambert Co.1986-03-17
SAULFON PW-70 A&B (P840031/S003)Lombart Lenses, Ltd.1986-03-17
AUTOBAC MIC TEST SYSTEM (N50524/S020)Organon Teknika Corp.1986-03-17
SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS (N17554/S006)Ciba Vision Care1986-03-17
AMERSHAM AFP (P780006/S002)Ortho Clinical Diagnostics1986-03-17
ACCUSEPT DISINFECTING UNIT (N17734/S005)Strieter Laboratories, Inc.1986-03-17
AUTOBAC MTS PLUS TEST SYTEM (P810024/S002)Warner-Lambert Co.1986-03-17
SOFTCON (VIFILCON A) SOFT CONTACT EXT WEAR LENS (P820021/S006)Alcon Laboratories, Inc.1986-03-17
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S016)Telectronics Pacing Systems, Inc.1986-03-14
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S023)Telectronics Pacing Systems, Inc.1986-03-14
COLLACOTE(TM) (P840062/S001)Integra Lifesciences Corp.1986-03-13
POSTERIOR CHAMBER INTRAOCULAR LENSES (P810018/S015)Alcon Laboratories1986-03-12
MODELS PC10 & PC21 (P820049/S003)Advanced Medical Optics, Inc.1986-03-11
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S024)Telectronics Pacing Systems, Inc.1986-03-11
MODEL AC10 & AC20 IOLS (P810056/S002)Advanced Medical Optics, Inc.1986-03-11
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S014)Telectronics Pacing Systems, Inc.1986-03-11
POSTERIOR CHAMBER INTRAOCULAR LENSES (P810018/S014)Alcon Laboratories1986-03-11
AQUASEPT II (N17679/S009)CooperVision, Inc.1986-03-10
HYDRACON(R) CONTACT LENSES (P820017/S012)Hydracon1986-03-10
MODELS PC10 & PC21 (P820049/S007)Advanced Medical Optics, Inc.1986-03-07
TANDEM(R)-E AFP (P840035/S001)Beckman Coulter, Inc.1986-03-06
DIPLOS MODEL 03 (P820076/S003)Biotronik, Inc.1986-03-06
COSMOS(TM) SYSTEM (P830026/S014)Boston Scientific1986-03-06
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S003)Hybritech, Inc.1986-03-06
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S016)Advanced Cardiovascular Systems, Inc.1986-03-06
SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE (P810046/S015)Advanced Cardiovascular Systems, Inc.1986-03-06
SAUFLON(R) PW (LIDOFILCON B) (P790020/S032)Advanced Medical Optics, Inc.1986-03-04
NATUREVUE CONTACT LENSE (N17676/S015)Bausch & Lomb, Inc.1986-03-04
CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC (P820072/S008)Bausch & Lomb, Inc.1986-03-03
SOFTSITE (HEFILCON A) CONTACT LENS (N17793/S011)Unilens Corporation, USA1986-03-03
LIFESPAN(TM) 100 TCPCO2 MONITOR (P820019/S007)Biochem International, Inc.1986-03-03
CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC (P820072/S010)Bausch & Lomb, Inc.1986-02-28
AMMENDMENT TO E. COLI ASC (N50510/S022)Biomerieux Vitek, Inc.1986-02-28
OPTIFLEX ANTERIOR CHAMBER LENSES (L1-L5) (P820035)Alcon1986-02-28
POLYVIOLENE SUTURE (N80950/S002)Look, Inc.1986-02-28
ALGES(TM) (HEFILCON A) CONTACT LENS (P850002/S001)Unilens Corp., USA1986-02-28
VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR (P820003/S023)Medtronic Cardiac Rhythm Disease Management1986-02-26
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048)Beckman Coulter, Inc.1986-02-25
AQUASEPT II (N17679/S006)CooperVision, Inc.1986-02-25
SOFLENS (N16895/S040)Bausch & Lomb, Inc.1986-02-24
PHYSIO-STIM(TM) I & II MODEL 6000 & 7000 (P850007)Orthofix, Inc.1986-02-21
CHAMBER LENS MODELS 101, 101B, 101T (P790027/S020)Bausch & Lomb1986-02-21
MODEL 91-50 IOL (P820044/S002)Bausch & Lomb, Inc.1986-02-21
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO (P800043/S004)Radiometer America, Inc.1986-02-21
NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM (P830055/S007)Depuy, Inc.1986-02-21
SOFLENS (N16895/S029)Bausch & Lomb, Inc.1986-02-21
MODELS 019B, 019C, 019E, 019F, 019J, & 019K (P810055/S013)Advanced Medical Optics, Inc.1986-02-20
SOFTHERM SOL. (N18078/S013)Advanced Medical Optics, Inc.1986-02-20
OCU-FLEX (P820051/S002)Ocu-Ease Optical Products, Inc.1986-02-20
MODELS PC10 & PC21 (P820049/S005)Advanced Medical Optics, Inc.1986-02-19
Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy (P850022)Ahp Eos Buyer, Inc.1986-02-18
ALCON ENZYME CLEANER (P820001/S007)Alcon Laboratories1986-02-14
COSMOS(TM) SYSTEM (P830026/S002)Boston Scientific1986-02-12
CORDIS SEQUICOR THETA MODELS 233D & 233E (P820014/S022)Telectronics Pacing Systems, Inc.1986-02-12
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S005)Pacesetter Systems1986-02-12
DIPLOS MODEL 03 (P820076/S001)Biotronik, Inc.1986-02-12
COSMOS(TM) SYSTEM (P830026/S013)Boston Scientific1986-02-12
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S015)Telectronics Pacing Systems, Inc.1986-02-12
AMMENDMENT TO E. COLI ASC (N50510/S021)Biomerieux Vitek, Inc.1986-02-11
DIASONICS NMR IMAGING SYSTEM (P830053/S009)Diasonics, Inc.1986-02-11
DIASONICS NMR IMAGING SYSTEM (P830053/S010)Diasonics, Inc.1986-02-11
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900 (P830054/S006)Coherent Medical Division1986-02-10
NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S003)Philips Medical Systems (Cleveland), Inc.1986-02-05
DORNIER LITHOTRIPTER, MODEL HM3 (P840008/S002)Dornier Medtech America, Inc.1986-02-05
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM (P840012)Meridian AG1986-01-31
SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS (P850077)CooperVision, Inc.1986-01-31
HYDRASOFT (METHAFILCON B) CONTACT LENS (P850079)CooperVision, Inc.1986-01-31
MODELS 019B, 019C, 019E, 019F, 019J, & 019K (P810055/S010)Advanced Medical Optics, Inc.1986-01-31
MODEL AC (AC1-AC5) (P810001/S001)Alcon1986-01-31
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Track 1986 automatically

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