Atlas FDA

2006

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

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◉ Watch 2006

RecordFirmDate
X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM (P040001/S004)Medtronic Sofamor Danek, Inc.2006-12-29
TRILOGY AB ACETABULAR SYSTEM (P040048/S001)Zimmer, Inc.2006-12-28
GUARDIAN RT (P980022/S014)Medtronic Minimed2006-12-27
DEXCOM STS SYSTEM (P050012/S005)Dexcom, Inc.2006-12-26
RADIESSE 1.3CC AND 0.3CC (P050037)Merz North America, Inc.2006-12-22
UVAR XTS PHOTOPHERESIS SYSTEM (P860003/S045)Therakos Development Limited2006-12-22
VASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT (P990037/S024)Vascular Solutions, Inc.2006-12-22
PROLIEVE THERMODILATATION SYSTEM (P030006/S012)Medifocus, Inc.2006-12-22
RADIESSE INJECTABLE IMPLANT (P050052)Merz North America, Inc.2006-12-22
OCUCOAT (P860047/S019)Bausch & Lomb, Inc.2006-12-21
VITALITY (P960040/S139)Boston Scientific2006-12-21
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S013)Boston Scientific Corp2006-12-21
VITALITY (P960040/S137)Boston Scientific2006-12-21
AFFINITY/ENTITY/IDENTITY ADX/INTREGRITY/INTEGRITY MICRO/VERITY ADX PACEMAKERS (P880086/S126)ABBOTT MEDICAL2006-12-21
CONTAK RENEWAL 3 (P010012/S144)Boston Scientific Corp2006-12-21
FRONTIER BIVENTRICULAR PACEMAKERS (P030035/S019)ABBOTT MEDICAL2006-12-21
AMS ACTICON NEOSPHINCTER (P010020/S002)Boston Scientific Corp2006-12-21
LIBERTE CORONARY STENT SYSTEM (P040016/S012)Boston Scientific Scimed, Inc.2006-12-21
BLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER (P920047/S036)Boston Scientific Corp2006-12-21
BLAZER II XP CATHETERS (P020025/S018)Boston Scientific2006-12-21
PROSTALUND OPERATIONS AB CORETHERM SYSTEM MICROWAVE THERMOTHERAPY (P010055/S003)Prostalund AB2006-12-21
CONTAK RENEWAL (P010012/S145)Boston Scientific Corp2006-12-21
KAPPA 400 MEDTRONIC IMPLANTABLE PULSE GENERATORS (P970012/S026)Medtronic, Inc.2006-12-21
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S033)Boston Scientific Corp2006-12-21
KAPPA 700, KAPPA 900, ENPULSE, ADAPTA/VERSA/ SENSIA (P980035/S067)Medtronic, Inc.2006-12-21
ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S061)ABBOTT MEDICAL2006-12-20
TAXUS EXPRESS PACLITAXEL- ELUTING CORONARY STENT SYSTEM (P030025/S041)Boston Scientific Corp2006-12-20
HYDRELLE (P050033)Anika Therapeutics, Inc.2006-12-20
OLYMPIC COOL-CAP (P040025)Natus Medical Incorporated2006-12-20
COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S025)Integra LifeSciences Corporation2006-12-19
COSMODERM/ COSMOPLAST COLLAGEN IMPLANT, COSMODERM COSMOPLAST HUMAN-BASED COLLAGEN IMPLANT (P800022/S055)Allergan2006-12-19
HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S022)Integra LifeSciences Corporation2006-12-19
BD 1% OVD (P960011/S012)Altacor , Ltd.2006-12-19
O2 OPTIX (LOTRAFILCON B) SOFT CONTACT LENSES (P010019/S005)Alcon Laboratories, Inc.2006-12-19
TMX-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM (P000043/S015)Boston Scientific Corp2006-12-15
CHARITE ARTIFICIAL DISC (P040006/S003)Depuy Spine, Inc.2006-12-15
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S011)Biomet Manufacturing Corp2006-12-15
THE SPANNER TEMPORARY PROSTATIC STENT (P060010)Srs Medical2006-12-14
CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM & EPIC HF (P030054/S046)ABBOTT MEDICAL2006-12-14
ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980035/S068)Medtronic, Inc.2006-12-14
ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR, EPIC II/II+ DR/VR/HR, ATLAS, ATLAS+, AND ATLAS II/II+ ICD SYSTEMS (P910023/S128)ABBOTT MEDICAL2006-12-14
ENRHYTHM IMPLANTABLE PULSE GENERATOR AND ENTRUST IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P980016/S091)Medtronic Cardiac Rhythm Disease Management2006-12-14
ST. JUDE MEDICAL HOUSECALL PLUS SYSTEM (P910023/S127)ABBOTT MEDICAL2006-12-14
RIATA LEAD MODELS 1580, 1581 AND 1582; RIATA, RIATA ST AND RIATA ST OPTIM LEAD FAMILIES (P950022/S032)ABBOTT MEDICAL2006-12-14
RX ACCULINK & ACCULINK CAROTID STENT SYSTEM (P040012/S024)Abbott Vascular2006-12-14
VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD) (P990052/S014)Med-El Elektromedizinische Gerate GmbH2006-12-14
FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE (P950020/S022)Boston Scientific Corp2006-12-14
GORE HELEX SEPTAL OCCLUDER (P050006/S002)W. L. Gore & Associates, Inc.2006-12-13
VIBRANT SOUNDBRIDGE (P990052/S015)Med-El Elektromedizinische Gerate GmbH2006-12-13
ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS (P030054/S045)ABBOTT MEDICAL2006-12-13
ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS (P910023/S126)ABBOTT MEDICAL2006-12-13
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S035)Boston Scientific Corp2006-12-11
PIN PLUG, DF-1 Y-ADAPTER/ EXTENDER, LEAD ASSEMBLY SILICONE DEFIBRILLATOR (P920015/S036)Medtronic, Inc.2006-12-11
TENDRIL 1688T/TC LEADS (P960013/S024)ABBOTT MEDICAL2006-12-11
CORONARY DILATATION CATHETERS (P810046/S220)Advanced Cardiovascular Systems, Inc.2006-12-11
LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S016)Boston Scientific Scimed, Inc.2006-12-11
ACTIVE CAN EMULATOR CONNECTOR, TRANSVERSE EPICARDIAL DEFIBRILLATION LEAD, LEAD SLEEVE ADAPTER KIT (P900061/S070)Medtronic Cardiac Rhythm Disease Management2006-12-11
VOYAGER RX CORONARY DILATATION CATHETER (P810046/S221)Advanced Cardiovascular Systems, Inc.2006-12-11
FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM (P890043/S039)Abbott Vascular2006-12-11
EXPRESS2 CORONARY STENT SYSTEM (P020009/S029)Boston Scientific Scimed, Inc.2006-12-11
LEGACY SR IPG (P850051/S064)Medtronic, Inc.2006-12-11
LEGACY DR, WRENCH ACCESSORY KIT (P890003/S113)Medtronic, Inc.2006-12-11
VASCULAR DRIVER MX2 CORONARY STENT SYSTEM& MIRCODRIVER MX2 CORONARY STENT SYSTEM (P030009/S008)Medtronic, Ireland2006-12-08
X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM (P040001/S001)Medtronic Sofamor Danek, Inc.2006-12-08
CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S031)Cordis Corp.2006-12-07
LUMAX FAMILY OF ICDS/CRT-DS (P000009/S020)Biotronik, Inc.2006-12-07
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S032)Cordis Corp.2006-12-07
LUMAX FAMILY OF ICDS/CRT-DS (P050023/S001)Biotronik, Inc.2006-12-07
ANGIOJET ULTRA THROMBECTOMY SYSTEM (P980037/S014)Boston Scientific Corp2006-12-07
LUMAX IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P950037/S046)Biotronik, Inc.2006-12-07
LUMAX FAMILY OF ICDS/CRT-DS (P980023/S025)Biotronik, Inc.2006-12-07
MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P910077/S067)Boston Scientific2006-12-06
ZENITH AAA ENDOCASCULAR GRAFT WITH H + L-B ONE-SHOT INTRODUCTION SYSTEM (P020018/S019)Cook, Inc.2006-12-06
ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S020)Cook, Inc.2006-12-06
FLEXTOME CUTTING BALLOON MONORAIL & OVER-THE-WIRE (P950020/S021)Boston Scientific Corp2006-12-06
CONTAK RENEWAL TR FAMILY (P030005/S040)Guidant Corp.2006-12-06
PRIZM/VITALITY FAMILY (P960040/S136)Boston Scientific2006-12-06
MERIDIAN/DISCOVERY FAMILY (P940031/S060)Boston Scientific2006-12-06
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S016)W. L. Gore & Associates, Inc.2006-12-06
LI61AO LENS (P910061/S015)Bausch & Lomb2006-12-06
CONTAK RENEWAL FAMILY (P010012/S143)Boston Scientific Corp2006-12-06
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S006)Boston Scientific Corp2006-12-05
UROLUME URETHRAL STENT (P920023/S019)Boston Scientific Corp2006-12-05
TENDRILL SDX LEAD MODELS 1488T/1488TC (P960013/S023)ABBOTT MEDICAL2006-12-05
ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S003)Boston Scientific Corp2006-12-05
DURASEAL DURAL SEALANT SYSTEM (P040034/S006)Integra LifeSciences Corporation2006-12-04
NAVISTAR THERMOCOOL CATHETER (P040036/S001)Biosense Webster, Inc.2006-12-04
FLOSEAL HEMOSTATIC MATRIX (P990009/S018)Baxter Healthcare Corp2006-12-01
BOSTON SCIENTIFIC XP APM (AUTOMATIC PERSONALITY MODULE) UNIT, MODEL 822T (P920047/S035)Boston Scientific Corp2006-12-01
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES ? HEALON, HEALON GV, AND HEALON5 (P810031/S032)Johnson & Johnson Surgical Vision, Inc.2006-12-01
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S136)ABBOTT MEDICAL2006-11-30
EPIC HF/ATLAS+HF FAMILY OF CRT-DS (P030054/S043)ABBOTT MEDICAL2006-11-30
MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER (P970013/S014)ABBOTT MEDICAL2006-11-30
CADENCE FAMILY OF ICDS (P910023/S124)ABBOTT MEDICAL2006-11-30
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S047)St. Jude Medical, Inc.2006-11-30
PARAGON/PHOENIX FAMILY OF PACEMAKERS (P830045/S104)St. Jude Medical, Inc.2006-11-30
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S026)ABBOTT MEDICAL2006-11-30
ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S021)Cook, Inc.2006-11-29
VICTORY PULSE GENERATORS (P880086/S138)ABBOTT MEDICAL2006-11-29
SELECTED FAMILIES OF ICD'S (P980016/S089)Medtronic Cardiac Rhythm Disease Management2006-11-29
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Track 2006 automatically

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