Atlas FDA

2009

1,492 FDA 510(k) clearances · PMA decision year

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◉ Watch 2009

RecordFirmDate
STRATOS LV AND LV-T PULSE GENERATORS (P070008/S008)Biotronik, Inc.2009-03-31
TELIGEN (P960040/S191)Boston Scientific2009-03-31
CONSULTA CRT-D, MAXIMO II CRT-D AND CONCERTO II CRT-D (P010031/S131)Medtronic Cardiac Rhythm Disease Management2009-03-31
SECURA DR/VR MAXIMO II DR/VR AND VIRTUOSO II DR/VR (P980016/S164)Medtronic Cardiac Rhythm Disease Management2009-03-31
LUMAX FAMILY OF ICDS (P050023/S019)Biotronik, Inc.2009-03-31
COGNIS (P010012/S204)Boston Scientific Corp2009-03-31
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S028)CooperSurgical, Inc.2009-03-27
ACTIVA RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM (P960009/S051)Medtronic, Inc.2009-03-27
SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD (P060027/S007)MicroPort CRM USA, Inc.2009-03-26
COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S018)Integra Lifesciences Corp.2009-03-26
MEDTRONIC MODEL 2490C CARELINK MONITORS (P890003/S167)Medtronic, Inc.2009-03-26
NEXGEN COMPLETE KNEE SOLUTION (P060037/S005)Zimmer, Inc.2009-03-26
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S032)Integra LifeSciences Corporation2009-03-26
RIATA & DURATA FAMILY OF LEADS (P950022/S054)ABBOTT MEDICAL2009-03-26
HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S029)Integra LifeSciences Corporation2009-03-26
BIOFINITY (COMFILCON A) SOFT CONTACT LENS (P080011/S001)CooperVision, Inc.2009-03-25
CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12 (P960042/S010)Spectranetics (Philips)2009-03-25
SPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM (P910001/S027)Spectranetics Corp.2009-03-25
COMBI 40+ COCLEAR IMPLANT SYSTEM (P000025/S040)Med-El Corp.2009-03-25
MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038/S003)Corcym Canada Corp2009-03-25
HANCOCK PORCINE BIOPROSTHETIC VALVED CONDUIT AND HANCOCK TROCAR BLADES AND HANDLE (P870078/S006)Medtronic, Inc.2009-03-25
ATS OPEN PIVOT HEART VALVE (P990046/S020)Medtronic Ats Medical, Inc.2009-03-24
VARIOUS FAMILIES OF ICDS (P980016/S182)Medtronic Cardiac Rhythm Disease Management2009-03-24
CADENCE FAMILY OF ICDS (P910023/S202)ABBOTT MEDICAL2009-03-23
BELOS VR-T, DR-T & A+-T; LEXOS DR-T & VR-T; XELOS DR-T; LUMOS DR-T & VR-T (P000009/S034)Biotronik, Inc.2009-03-23
LUMAX FAMILY OF ICDS AND KRONOS LV-T (P050023/S021)Biotronik, Inc.2009-03-23
CYPHER SIROLIMUS-ELUTING CORONARY STENTS (P020026/S050)Cordis Corp.2009-03-23
EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S118)ABBOTT MEDICAL2009-03-23
STRATOS LV-T (P070008/S010)Biotronik, Inc.2009-03-23
PHILOS DR-T, PHILOSII DR-T AND CYLOS DR-T (P950037/S069)Biotronik, Inc.2009-03-23
TALENT THORACIC STENT GRAFT SYSTEM (P070007/S004)Medtronic Vascular2009-03-23
TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S004)Medtronic Vascular2009-03-23
UVAR CELLEX PHOTOPHERESIS SYSTEM (P860003/S048)Therakos Development Limited2009-03-20
ENDEAVOR ZOTAROLIMUS/SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS (P060033/S026)Medtronic, Inc.2009-03-20
TALENT THORACIC STENT GRAFT SYSTEM (P070007/S008)Medtronic Vascular2009-03-20
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S059)Boston Scientific Corp2009-03-20
PRECISION SPINAL CORD STIMULATOR SYSTEM (P030017/S088)Boston Scientific Corp2009-03-20
GORE VIABAHN ENDOPROSTHESIS (P040037/S017)W. L. Gore & Associates, Inc.2009-03-20
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S022)Boston Scientific Corp2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK & CALIBRATORS (P000014/S018)Ortho-Clinical Diagnostics, Inc.2009-03-19
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S027)Boston Scientific Corp2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS (P000044/S021)Ortho-Clinical Diagnostics, Inc.2009-03-19
CERVICAL IMAGING SYSTEM (P040028/S004)Spectra Science2009-03-19
EON MINI IPG NEUROSTIMULATION SYSTEM (P010032/S028)ABBOTT MEDICAL2009-03-19
AMS 800 URINARY CONTROL SYSTEM (P000053/S021)Boston Scientific Corp2009-03-19
RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS (P840001/S132)Medtronic Neuromodulation2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATORS (P030024/S011)Ortho-Clinical Diagnostics2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS (P010021/S015)Ortho-Clinical Diagnostics, Inc.2009-03-19
ACTIVA THERAPY FOR DBS (P960009/S064)Medtronic, Inc.2009-03-19
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATORS (P030026/S017)Ortho-Clinical Diagnostics, Inc.2009-03-19
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S079)Advanced Bionics2009-03-18
COGNIS & LIVIAN (P010012/S203)Boston Scientific Corp2009-03-18
TELIGEN & CONFIENT (P960040/S190)Boston Scientific2009-03-18
AB PORTABLE DRIVER (P900023/S049)Abiomed Cardiovascular, Inc.2009-03-17
MEDTRONIC VASCULAR TALENT ABDOMINAL STANT GRAFT SYSTEM (P070027/S008)Medtronic Vascular2009-03-16
MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM (P070007/S007)Medtronic Vascular2009-03-16
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S015)Hologic, Inc.2009-03-16
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S018)Bayer Pharma AG2009-03-16
ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES (P930014/S031)Alcon Laboratories, Inc.2009-03-16
RESTOR POSTERIOR CHAMBER INTRAOCULAR LENSES (P040020/S013)Alcon Research, Ltd.2009-03-16
ENTRUST ICDS (P980016/S178)Medtronic Cardiac Rhythm Disease Management2009-03-16
XIENCE V AND PROMUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P070015/S013)Abbott Vascular, Inc.2009-03-16
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S076)Boston Scientific Corp2009-03-16
SYNCHROMED INFUSION SYSTEM (P860004/S104)Medtronic, Inc.2009-03-13
THE TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S006)Medtronic Vascular2009-03-13
THORATEC HEARTMATE II LVAS (P060040/S001)ABBOTT MEDICAL2009-03-13
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
THORATEC HEARTMATE XVE LVAS (P920014/S029)Thoratec Corp2009-03-13
EXOGEN 4000+ BONE HEALING SYSTEM (P900009/S030)Bioventus, LLC2009-03-13
APLIGRAF (P950032/S050)Organogenesis, Inc.2009-03-13
SOLETRA & KINETRA NEUROSTIMULATORS (P960009/S063)Medtronic, Inc.2009-03-12
ITREL 3 IMPLANTABLE PULSE GENERATOR/SYNERGY & RESTORE FAMILIES OF IMPLANTABLE NEUROSTIMULATORS (P840001/S130)Medtronic Neuromodulation2009-03-12
NC SPRINTER RAPID EXCHANGE BALLOON DILATATION CATHETER (P790017/S100)Medtronic, Ireland2009-03-12
CERVISTA HPV 16/18 (P080015)Hologic, Inc.2009-03-12
COGNIS CRT-DS (P010012/S202)Boston Scientific Corp2009-03-12
LEXOS & LUMOS FAMILIES OF ICDS (P000009/S030)Biotronik, Inc.2009-03-12
LUMAX FAMILIES OF ICDS (P050023/S017)Biotronik, Inc.2009-03-12
CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT (P080014)Hologic, Inc.2009-03-12
INTERSTIM FAMILY OF NEUROSTIMULATORS (P970004/S071)Medtronic Neuromodulation2009-03-12
TELIGEN ICDS (P960040/S189)Boston Scientific2009-03-12
X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM (P040001/S013)Medtronic Sofamor Danek, Inc.2009-03-11
SECURA DR/VR, VIRTUOSO II DR/VR AND MAXIMO II DR/VR (P980016/S175)Medtronic Cardiac Rhythm Disease Management2009-03-11
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S010)Abbott Vascular, Inc.2009-03-11
CONSULTA CRT-D, CONCERTO II CRT-D AND MAXIMO II CRT-D (P010031/S141)Medtronic Cardiac Rhythm Disease Management2009-03-11
STAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P990013/S025)Starr Surgical Co.2009-03-11
SYNVISC & SYNVISC-ONE (HYLAN G-F 20) (P940015/S014)Sanofi Genzyme Corp.2009-03-11
COAPTITE INJECTABLE IMPLANT (P040047/S011)Merz North America, Inc.2009-03-11
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S074)Advanced Bionics2009-03-11
STAAR SURGICAL IMPLANTABLE COLLAMER LENS FOR MYOPIA (P030016/S012)STAAR Surgical Company2009-03-11
CONTAK RENEWAL TR PULSE GENERATORS (P030005/S056)Guidant Corp.2009-03-11
STAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE (P000026/S002)Starr Surgical Co.2009-03-11
FC2 FEMALE CONDOM (P080002)Clear Future, Inc.2009-03-10
SPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE (P060010/S003)Srs Medical2009-03-10
CONCERTO (P010031/S127)Medtronic Cardiac Rhythm Disease Management2009-03-09
VIRTUOSO (P980016/S159)Medtronic Cardiac Rhythm Disease Management2009-03-09
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S023)Bayer Pharma AG2009-03-09
DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S090)Medtronic Cardiac Rhythm Disease Management2009-03-09
TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P070007/S006)Medtronic Vascular2009-03-09
TALENT ABDOMINAL STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P070027/S007)Medtronic Vascular2009-03-09
VARIOUS TEMPORARY PACEMAKER MODELS (P820003/S086)Medtronic Cardiac Rhythm Disease Management2009-03-09
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Every clearance here is in the API, with alerts when new ones post.