Atlas FDA

2012

2,411 FDA 510(k) clearances · PMA decision year

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◉ Watch 2012

RecordFirmDate
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S017)Siemens Healthcare Diagnostics2012-03-22
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S086)Edwards Lifesciences, LLC2012-03-22
CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS MODEL# 6625LP AND 6625-ESR-LP (P870077/S042)Edwards Lifesciences, LLC2012-03-22
LINX REFLUX MANAGEMENT SYSTEM (P100049)Torax Medical2012-03-22
REVO MRI (P090013/S054)Medtronic, Inc.2012-03-22
ENTRUST / VIRTUOSO / PROTECTA (P980016/S340)Medtronic Cardiac Rhythm Disease Management2012-03-22
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P (P000007/S029)Edwards Lifesciences, LLC2012-03-22
EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX (P100041/S007)Edwards Lifesciences, LLC2012-03-22
ARCHITECT TOTAL PSA (P910007/S034)Abbott Laboratories2012-03-22
CARPENTIER-EDWARDS SUPRAANULAR BIOPROSTHESIS MODEL 2650 (P010041/S031)Edwards Lifesciences, LLC2012-03-22
SCULPTRA (P030050/S011)Q-Med AB2012-03-22
ENRHYTHM / ENRHYTHM MRI (P980035/S261)Medtronic, Inc.2012-03-22
PIPELINE EMBOLIZATION DEVICE (P100018/S004)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2012-03-22
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S032)Vistakon, Division of Johnson & Johnson Vision Car2012-03-21
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S078)St. Jude Medical, Inc.2012-03-21
MICRONY FAMILY OF PACEMAKERS (P970013/S047)ABBOTT MEDICAL2012-03-21
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S217)ABBOTT MEDICAL2012-03-21
CADENCE/CURRENT FAMILY OF ICDS (P910023/S293)ABBOTT MEDICAL2012-03-21
FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S095)ABBOTT MEDICAL2012-03-21
ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT (P940035/S008)Abbott Diagnostics Scarborough, Inc.2012-03-21
MEDTRONIC SPRINT QUATTRO SECURE DF4 LEAD MODEL 6947M (P920015/S086)Medtronic, Inc.2012-03-21
EPIC HF/ATLAS+ HF/ATLAS+ HF/PROMOTE FAMILY OF CRT-DS (P030054/S220)ABBOTT MEDICAL2012-03-21
ADIANA CONTRACEPTION SYSTEM (P070022/S025)Hologic, Inc.2012-03-20
ROCHE COBAS TAQMAN HBV TESTS (P050028/S020)Roche Molecular Systems, Inc.2012-03-20
HYDRELLE (P050033/S014)Anika Therapeutics, Inc.2012-03-20
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND RETROFLEX 3 DELIVERY SYSTEM (P100041/S006)Edwards Lifesciences, LLC2012-03-20
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S023)Allergan2012-03-20
COBAS TAQMAN HCV TESTS (P060030/S021)Roche Molecular Systems, Inc.2012-03-20
MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S011)Corcym Canada Corp2012-03-19
PROGEL PLEURAL AIR LEAK SEALANT (P010047/S015)Neomend, Inc.2012-03-19
ELECSYS HBSAG (HBSAG) TEST SYSTEM (P990012/S012)Roche Diagnostics Corp.2012-03-19
COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S022)Integra Lifesciences Corp.2012-03-19
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S035)Bayer Pharma AG2012-03-19
DIMENSION TPSA FLEX REAGENT CARTRIDGE (P000021/S022)Siemens Healthcare Diagnostics2012-03-16
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S045)W. L. Gore & Associates, Inc.2012-03-16
DIMENSION FPSA FLEX REAGENT CARTRIDGE (P020027/S018)Siemens Healthcare Diagnostics2012-03-16
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S070)W. L. Gore & Associates, Inc.2012-03-16
LCS TOTAL KNEE SYSTEM (P830055/S124)Depuy, Inc.2012-03-16
ATTAIN ABILITY, ATTAIN ABILITY PLUS & ATTAIN ABILITY STRAIGHT (P080006/S039)Medtronic, Inc.2012-03-16
INFUSE BONE GRAFT (P050053/S020)Medtronic, Inc.2012-03-15
PUNCTUA ICD MODELS (E050, E051, E052, E052), ENERGEN ICD MODELS (E140, E141, E142, E143) INCEPTA ICD MODELS (E160, E161, (P960040/S252)Boston Scientific2012-03-15
INFUSE BONE GRAFT (P000054/S029)Medtronic Sofamor Danek USA, Inc.2012-03-15
STRATOS LV/LV-T (P070008/S030)Biotronik, Inc.2012-03-15
VARIOUS FAMILIES OF PHILOS, CYLOS, EVIA, ENTOVIS, ESTELLA, ECURO, & EFFECTA IMPLANTABLE PACEMAKERS (P950037/S104)Biotronik, Inc.2012-03-15
STELID II BTF/BJF STEROID COLLAR (P020030/S007)MicroPort CRM USA, Inc.2012-03-15
BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S (P000009/S048)Biotronik, Inc.2012-03-15
TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM (P020016/S006)Biomet Microfixation, Inc.2012-03-15
INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE (P000058/S042)Medtronic Sofamor Danek USA, Inc.2012-03-15
PUNCTUA CRT-D MODELS (N050, N051), ENERGEN CRT-D MODELS (N140, N141) INCEPTA CRT-D MODELS (N160, N161, N164) (P010012/S282)Boston Scientific Corp2012-03-15
KRONOS LV-T CRT-D AND LUMAX 300/340 & 500/540 CRT-D'S & ICD'S (P050023/S052)Biotronik, Inc.2012-03-15
UNIFY FAMILY OF CRT-DS AND LEADS (P030054/S216)ABBOTT MEDICAL2012-03-14
RADIESSE INJECTABLE IMPLANT (P050052/S030)Merz North America, Inc.2012-03-14
RADIESSE INJECTABLE IMPLANT (P050037/S026)Merz North America, Inc.2012-03-14
RADIESSE INJECTABLE IMPLANT (P050052/S029)Merz North America, Inc.2012-03-14
FORTIFY FAMILY OF ICDS (P910023/S289)ABBOTT MEDICAL2012-03-14
RADIESSE INJECTABLE IMPLANT (P050037/S027)Merz North America, Inc.2012-03-14
SEN-SERTER, MODEL: MMT-7500 (P980022/S111)Medtronic Minimed2012-03-14
UROLOGIX TARGIS SYSTEM (P970008/S061)Urologix, LLC2012-03-13
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR (P000014/S025)Ortho-Clinical Diagnostics, Inc.2012-03-13
XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S082)Abbott Vascular, Inc.2012-03-13
PROMOTE Q/PROMOTE QUADRA/UNIFY QUADRA/QUARTET CRT-DS (P030054/S215)ABBOTT MEDICAL2012-03-12
AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S093)Advanced Bionics2012-03-12
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P890047/S038)Alcon Research, Ltd.2012-03-12
CADENCE ICD SYSTEM (P910023/S288)ABBOTT MEDICAL2012-03-12
ACRYSOF INTRAOCULAR LENSES (P930014/S059)Alcon Laboratories, Inc.2012-03-12
DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM (P840064/S050)Alcon Laboratories2012-03-12
OPHTEC-STABLEYES CAPSULAR TENSION RING (P030023/S002)Ophtec BV2012-03-12
ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S040)Alcon Research, Ltd.2012-03-12
PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR (P980016/S338)Medtronic Cardiac Rhythm Disease Management2012-03-09
BD FOCALPOINT SLIDE PROFILER (P950009/S014)Bd Diagnostics2012-03-09
ETI-MAK-2 PLUS ASSAY (P990038/S015)DiaSorin, Inc.2012-03-09
ETI-CORE-IGMK PLUS ASSAY (P990044/S012)DiaSorin, Inc.2012-03-09
ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT (P080006/S038)Medtronic, Inc.2012-03-09
CONSULTA CRT-P, SYNCRA CRT-P (P010015/S154)Medtronic, Inc.2012-03-09
ETI-EBK-PLUS (P990043/S015)DiaSorin, Inc.2012-03-09
DERMAL FILLER PRODUCT HYDRELLE (ELEVESS) (P050033/S013)Anika Therapeutics, Inc.2012-03-09
MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S109)Medtronic Minimed2012-03-09
PROTECTA CRT-D, PROTECTA XT CRT-D (P010031/S291)Medtronic Cardiac Rhythm Disease Management2012-03-09
ETI-AB-EBK PLUS ASSAY (P990041/S014)DiaSorin, Inc.2012-03-09
EPIC HF/ATLAS + HF FAMILY (P030054/S196)ABBOTT MEDICAL2012-03-09
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL) (P100023/S036)Boston Scientific Corp2012-03-09
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S040)Boston Scientific Corp2012-03-09
CADENCE FAMILY OF ICDS (P910023/S270)ABBOTT MEDICAL2012-03-09
SIENTRA SILICONE GEL BREAST IMPLANTS (P070004)Tiger Aesthetics Medical, LLC2012-03-09
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S129)Boston Scientific Corp2012-03-09
ETI-AB-AUK PLUS ASSAY (P990042/S011)DiaSorin, Inc.2012-03-09
REVO MRI SURESCAN (P090013/S053)Medtronic, Inc.2012-03-09
ETI-AB-COREK PLUS ASSAY (P990045/S012)DiaSorin, Inc.2012-03-09
BRYAN CERVICAL DISC (P060023/S001)Companion Spine France Sas2012-03-09
ADVISA DR (P980035/S260)Medtronic, Inc.2012-03-09
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P110010/S007)Boston Scientific Corp2012-03-09
RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES (P060011/S003)Rayner Intraocular Lenses , Ltd.2012-03-08
DEPUY DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM (P040023/S018)DePuy Orthopaedics, Inc.2012-03-08
DEXCOM SEVEN & SEVEN PLUS SYSTEM (P050012/S044)Dexcom, Inc.2012-03-08
BIOGLUE SURGICAL ADHESIVE (P010003/S016)Cryolife, Inc.2012-03-07
REVO MRI IPG (P090013/S051)Medtronic, Inc.2012-03-07
ADVISA DR, VERSA, ENRHYTHM, RELIA, & VARIOUS FAMILIES OF ADAPTA & SENSIA IPGS (P980035/S258)Medtronic, Inc.2012-03-07
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S090)Abbott Vascular, Inc.2012-03-07
INSYNC III MARQUIS & INSYNC MAXIMO ICDS (P010031/S288)Medtronic Cardiac Rhythm Disease Management2012-03-07
RX ZETA, OTW ZETA (P970020/S071)Abbott Vascular, Inc.2012-03-07
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Every clearance here is in the API, with alerts when new ones post.