Atlas FDA

2006

1,074 FDA 510(k) clearances · PMA decision year

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◉ Watch 2006

RecordFirmDate
MEDTRONIC 2490 A/C/D/E/G/H/J CARELINK MONITORS (P890003/S112)Medtronic, Inc.2006-11-29
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S028)Cordis Corp.2006-11-29
VARIOUS FAMILIES OF ICD'S (P900061/S069)Medtronic Cardiac Rhythm Disease Management2006-11-29
INSYNC FAMILIES OF CRT-ICD'S (P010031/S056)Medtronic Cardiac Rhythm Disease Management2006-11-29
VARIOUS FAMILIES OF PACEMAKERS (P980035/S066)Medtronic, Inc.2006-11-29
ONYX LIQUID EMBOLIC SYSTEM (P030004/S002)Ev3 Neurovascular2006-11-29
MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE INFUSION PUMP SYSTEM (P860004/S087)Medtronic, Inc.2006-11-22
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S137)ABBOTT MEDICAL2006-11-21
CADENCE FAMILY ICDS (P910023/S125)ABBOTT MEDICAL2006-11-21
ANGIOJET ULTRA THROMBECTOMY SYSTEM (XMI CATHETER) (P980037/S015)Boston Scientific Corp2006-11-21
XACT CAROTID STENT SYSTEM (P040038/S006)Abbott Vascular, Inc.2006-11-21
DRIVER AND MICRODRIVER CORONARY STENT SYSTEMS (P030009/S007)Medtronic, Ireland2006-11-21
INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S011)ETHICON, Inc.2006-11-21
PERCLOSE PROGLIDE 6 FRENCH SUTURE-MEDIATED CLOSURE (SMC) SYSTEMS (P960043/S060)Abbott Vascular, Inc.2006-11-21
MULTI-LINK RX AND OTW VISION AND MINI VISION CORONARY STENT SYSTEMS (P020047/S005)Abbott Vascular2006-11-21
EPIC HF FAMILY CRT-DS (P030054/S044)ABBOTT MEDICAL2006-11-21
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S027)ABBOTT MEDICAL2006-11-21
MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS (P030053)Mentor Corp.2006-11-17
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S015)Boston Scientific Corp2006-11-17
GEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT (P040013/S008)Lynch Biologics, LLC2006-11-17
NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056)Allergan2006-11-17
DURASEAL DURAL SEALANT SYSTEM (P040034/S003)Integra LifeSciences Corporation2006-11-17
CADENCE FAMILY ICDS (P910023/S123)ABBOTT MEDICAL2006-11-16
CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM (P030047/S001)Cordis US Corporation2006-11-16
EPIC HF FAMILY CRT-DS (P030054/S042)ABBOTT MEDICAL2006-11-16
PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY (P050031)CooperVision, Inc.2006-11-16
VARIOUS FAMILIES OF PACEMAKERS (P990001/S027)Medtronic, Inc.2006-11-15
INSYNC/INSYNC III CRT-IPGS (P010015/S025)Medtronic, Inc.2006-11-15
MEDTRONIC VIRTUOSO MODEL D154AWG/ D154VWC IMPLANTABLE DEVICES (P980016/S084)Medtronic Cardiac Rhythm Disease Management2006-11-15
VARIOUS FAMILIES OF ICDS (P980016/S087)Medtronic Cardiac Rhythm Disease Management2006-11-15
VARIOUS FAMILIES OF PACEMAKERS AND MEDTRONIC CARELINK MONITOR (MODEL 2490H) (P890003/S110)Medtronic, Inc.2006-11-15
KAPPA, ENPULSE, ADAPTA, SENSIA AND VERSA PACEMAKERS (P980035/S063)Medtronic, Inc.2006-11-15
RIATA FAMILY OF LEADS (P950022/S031)ABBOTT MEDICAL2006-11-15
KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/SENSIA, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM, AT500 (P980035/S064)Medtronic, Inc.2006-11-15
INSYNC II PROTECT, INSYNC III PROTECT, INTRINSIC 30, INTRINSIC, INSYNC SENTRY, INSYNC MAXIMO, CONCERTO (P010031/S054)Medtronic Cardiac Rhythm Disease Management2006-11-15
KAPPA 400 FAMILY OF PACEMAKERS (P970012/S025)Medtronic, Inc.2006-11-15
JEWEL AF, GEM II AT FAMILY OF ICDS (P980050/S025)Medtronic, Inc.2006-11-15
CONCERTO MODELS C154DWK (P010031/S051)Medtronic Cardiac Rhythm Disease Management2006-11-15
INSYNC MARQUIS MODEL 7277LINSYNC II MARQUIS MODEL 7289; INSYNC III MARQUIS MODEL 7279,INSYNC II PROTECT MODEL 7295; UNSY (P010031/S053)Medtronic Cardiac Rhythm Disease Management2006-11-15
MARQUIS DR/VR MODELS 7274,7230B,7230CX,7230E:MAXIMO DR/VR MODELS 7278,7232B,7232CX,7232E INTRINSIC MODELS 7288:ENTRUST D (P980016/S086)Medtronic Cardiac Rhythm Disease Management2006-11-15
GEM FAMILY OF ICDS (P900061/S067)Medtronic Cardiac Rhythm Disease Management2006-11-15
ST. JUDE MEDICAL BIOCOR VALVE AND BIOCOR SUPRA VALVE (P040021/S005)ABBOTT MEDICAL2006-11-14
THERAPY ABLATION CATHETER AND IBI 1500T CARDIAC ABLATION GENERATOR (P040014/S003)Irvine Biomedical, Inc.2006-11-13
CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S023)Cordis Corp.2006-11-09
SOLUS, ADDVENT, SOLUS II, SYNCHRONY, PHOENIX III, TRILOGY, AFFINITY, INTEGRITY, ENTITY, IDENTITY, VERITY AND VICTORY PAC (P880086/S135)ABBOTT MEDICAL2006-11-09
S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (P020036/S006)Cordis US Corporation2006-11-09
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODEL 2700TFX (P860057/S040)Edwards Lifesciences, LLC2006-11-08
NIDEK EC-5000 EXCIMER LASER (P970053/S010)Nidek Co., Ltd.2006-11-08
HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S021)Integra LifeSciences Corporation2006-11-08
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S024)Integra LifeSciences Corporation2006-11-08
FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES, CEEON MODELS 911A & 913A, TECNIS MODELS Z9000 (P990080/S010)Johnson & Johnson Surgical Vision, Inc.2006-11-08
ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN (P030019/S012)Anika Therapeutics, Inc.2006-11-08
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S014)Integra Lifesciences Corp.2006-11-08
COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING (P840062/S011)Integra Lifesciences Corp.2006-11-08
FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON MODELS 911A & 913A, TECNIS Z9000 (P990080/S011)Johnson & Johnson Surgical Vision, Inc.2006-11-08
SPRINT LEADS, TUNNELING TOOLS (P920015/S035)Medtronic, Inc.2006-11-07
INSYNC III, INSYNC, ATTAIN (P010015/S023)Medtronic, Inc.2006-11-07
MEDTRONIC HALL (P790018/S046)Medtronic Cardiac Surgery2006-11-07
CAPSURE EPICARDIAL LEADS (P950024/S008)Medtronic, Inc.2006-11-07
KAPPA 700, VITATRON, KAPPA 900, ENPULSE, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM, AT500 (P980035/S057)Medtronic, Inc.2006-11-07
KAPPA 400 (P970012/S023)Medtronic, Inc.2006-11-07
VARIOUS FAMILIES OF ICDS (P980016/S074)Medtronic Cardiac Rhythm Disease Management2006-11-07
GEM III AT ICD & TRANSVENE LEAD (P980050/S023)Medtronic, Inc.2006-11-07
VARIOUS MODELS OF INSYNC ICDS (P010031/S041)Medtronic Cardiac Rhythm Disease Management2006-11-07
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) GEM (P900061/S065)Medtronic Cardiac Rhythm Disease Management2006-11-07
CAPSURE PACING LEADS (P850089/S054)Medtronic Cardiac Rhythm Disease Management2006-11-07
MEDTRONIC SELECTSECURE LEADS (P030036/S001)Medtronic Cardiac Rhythm Disease Management2006-11-07
LEGACY D, LEGACY S, LEGACY II, VISA, CAPSURE PACING LEADS (P890003/S104)Medtronic, Inc.2006-11-07
FOLDABLE ULTRAVIOLET LIGHT ABSORING POSTERIOR CHAMBER INTRACOCULAR LENSES (IOLS) CEEON MODELS 911A AND 913A AND TECNIS (P990080/S012)Johnson & Johnson Surgical Vision, Inc.2006-11-06
ADVIA IMS PROSTATE SPECIFIC ANTIGEN ASSAY (PSA) (P990055/S009)Siemens Healthcare Diagnostics2006-11-06
ADVIA IMS COMPLEXED PROSTATE SPECIFIC ANTIGEN ASSAY (CPSA) (P950021/S008)Siemens Healthcare Diagnostics2006-11-06
FLEXTOME CUTTING BALLOON MONORAIL (P950020/S020)Boston Scientific Corp2006-11-05
ZYDERM/ZYPLAST COLLAGEN, COSMODERM/ COSMOPLAST HUMAN COLLAGEN IMPLANT (P800022/S053)Allergan2006-11-03
VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM (P930016/S026)Amo Manufacturing USA, LLC2006-11-03
COSEAL SURGICAL SEALANT, PREMIXED (P030039/S002)Baxter Bio Science2006-11-03
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S037)Corcym S.r.l.2006-11-03
VNS THERAPY SYSTEM (P970003/S073)LivaNova USA, Inc.2006-11-02
DURASEAL DURAL SEALANT SYSTEM (P040034/S007)Integra LifeSciences Corporation2006-11-02
VIBRANT SOUNDBRIDGE (P990052/S013)Med-El Elektromedizinische Gerate GmbH2006-11-02
VNS THERAPY SYSTEM (P970003/S072)LivaNova USA, Inc.2006-11-02
LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE (P970043/S026)Alcon Laboratories2006-11-01
RAPIDSCREEN RS-2000D (P000041/S005)Riverain Medical Group2006-11-01
ANGIOLINK VASCULAR CLOSURE SYSTEM (P040022/S002)Medtronic Vascular2006-11-01
ENDOLOGIX POWERLINK SYSTEM (P040002/S007)Endologix, LLC2006-11-01
EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) (P900009/S024)Bioventus, LLC2006-11-01
LIFEVEST (WCD 3100) DEVICE (P010030/S007)Zoll Manufacturing Corporation2006-11-01
VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) W/UV BLOCKER (N18033/S040)Vistakon, Johnson & Johnson Vision Products, Inc.2006-10-31
VNS THERAPY SYSTEM (P970003/S074)LivaNova USA, Inc.2006-10-31
MACROPLASTIQUE IMPLANTS (P040050)Uroplasty, LLC2006-10-30
TUPOS LV/ATX & KRONOS LV-T CRT-DS & COROX OTW STEROID LV PACING LEAD (P050023/S002)Biotronik, Inc.2006-10-30
AFFINITY/INTREGITY/VICTORY FAMILY PACEMAKERS (P880086/S134)ABBOTT MEDICAL2006-10-27
FRONTIER/FRONTIER II FAMILY OF CRT-P'S (P030035/S025)ABBOTT MEDICAL2006-10-27
CADENCE FAMILY OF ICDS (P910023/S122)ABBOTT MEDICAL2006-10-27
EPIC HF/ATLAS+ HF FAMILY OF CRT-DS (P030054/S041)ABBOTT MEDICAL2006-10-27
ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM (P050025)Boston Scientific2006-10-27
ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER (P020012)Tiger Aesthetics Medical, LLC2006-10-27
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S040)Boston Scientific Corp2006-10-26
ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S017)Cook, Inc.2006-10-25
SENSOLOG/DIALOG/REGENCY FAMILY PACEMAKERS (P880006/S045)St. Jude Medical, Inc.2006-10-25
PARAGON/PHOENIX FAMILY PACEMAKERS (P830045/S102)St. Jude Medical, Inc.2006-10-25
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Every clearance here is in the API, with alerts when new ones post.