Atlas FDA

2007

1,116 FDA 510(k) clearances · PMA decision year

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◉ Watch 2007

RecordFirmDate
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) (P930016/S027)Amo Manufacturing USA, LLC2007-11-09
MARQUIS, MAXIMO AND EN TRUST DEVICE (P980016/S110)Medtronic Cardiac Rhythm Disease Management2007-11-09
CARDIOMESSENGER TLINE (P000009/S023)Biotronik, Inc.2007-11-09
CARDIOMESSENGER (CM LLT, CM T LINE AND CM II) (P050023/S007)Biotronik, Inc.2007-11-09
INSYNC MARQUIS, INSYNC SENTRY, AND INSYNC MAXIMO FAMILIES (P010031/S080)Medtronic Cardiac Rhythm Disease Management2007-11-09
VARIOUS FAMILIES OF PACEMAKERS (P980035/S078)Medtronic, Inc.2007-11-09
CORDIS PRECISE NITINOL STENT SYSTEM (P030047/S007)Cordis US Corporation2007-11-08
INTERSTIM NEUROSTIMULATOR (P970004/S044)Medtronic Neuromodulation2007-11-08
ITREL 3,RESTORE,RESTORE ADVANCED IMPLANTABLE NEUROSTIMULATOR (P840001/S101)Medtronic Neuromodulation2007-11-08
SOLETRA NEUROSTIMULATOR (P960009/S044)Medtronic, Inc.2007-11-08
INTERSTIM FOR URINARY CONTROL (P970004/S041)Medtronic Neuromodulation2007-11-07
MICRONY FAMILY OF PACEMAKERS/PACEMAKER PROGRAMMER (P970013/S020)ABBOTT MEDICAL2007-11-06
ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLS (P060035)Abbott Laboratories2007-11-06
PRIZM & VITALITY FAMILIES (P960040/S150)Boston Scientific2007-11-06
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S034)ABBOTT MEDICAL2007-11-06
PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S015)Smiths Medical Asd, Inc.2007-11-06
EPIC HF/ATLAS+ FAMILY OF CRT-DS (P030054/S070)ABBOTT MEDICAL2007-11-06
RENEWAL 3 RF FAMILIES (P010012/S157)Boston Scientific Corp2007-11-06
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S053)St. Jude Medical, Inc.2007-11-06
CADENCE FAMILY OF ICDS (P910023/S157)ABBOTT MEDICAL2007-11-06
LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE (P910077/S077)Boston Scientific2007-11-06
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S151)ABBOTT MEDICAL2007-11-06
TMR2000 HOLMIUM LASER SYSTEM (P970029/S011)Cryolife, Inc.2007-11-05
GYNECARETHERMACHOICE III UTERINE BALLOON THERAPY SYSTEM (P970021/S015)Gynecare, Inc.2007-11-05
AMS 800 URINARY CONTROL SYSTEM (P000053/S013)Boston Scientific Corp2007-11-05
EON NEUROSTIMULATION SYSTEM (P010032/S022)ABBOTT MEDICAL2007-11-05
CORMET HIP RESURFACING SYSTEM (P050016/S002)Corin USA2007-11-02
HTA SYSTEM (P000040/S012)Axora Medical, Inc.2007-11-02
PASSIVE FIXATION FAMILY OF LEADS (P880086/S154)ABBOTT MEDICAL2007-10-31
LIFEVEST WCD 3000 (P010030/S008)Zoll Manufacturing Corporation2007-10-31
CARDIOVASCULAR PERMANENT PACEMAKERS (P960030/S018)ABBOTT MEDICAL2007-10-31
ACTIVE FIXATION FAMILY OF LEADS (P960013/S034)ABBOTT MEDICAL2007-10-31
LEFT VENTRICULAR FAMILY OF LEADS (P030035/S035)ABBOTT MEDICAL2007-10-31
LEFT VENTRICULAR FAMILY OF LEADS (P030054/S071)ABBOTT MEDICAL2007-10-31
CONNECTOR-M1 (P030017/S025)Boston Scientific Corp2007-10-30
SENSAR & TECNIS ONE-PIECE ACRYLIC POSTERIOR CHAMBER IOLS (MODELS AAB00 & ZCB00) (P980040/S015)Johnson & Johnson Surgical Vision, Inc.2007-10-30
HELITAPE AND HELIPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY (P840062/S014)Integra Lifesciences Corp.2007-10-30
DEFLUX INJECTABLE GEL (P000029/S032)Palette Life Sciences2007-10-30
MULTI-LINK VISION RX ZETA CORONARY STENT SYSTEMS (P970020/S050)Abbott Vascular, Inc.2007-10-29
QUIKSTAR FAMILY OF CATHETERS (P990025/S014)Biosense Webster, Inc.2007-10-29
CELSIUS & EZ STEER FAMILIES OF CATHETERS (P950005/S023)Biosense Webster, Inc.2007-10-29
NAVISTAR FAMILY OF CATHETERS (P040036/S004)Biosense Webster, Inc.2007-10-29
NAVISTAR & CELSIUS FAMILIES OF CATHETERS (P030031/S007)Biosense Webster, Inc.2007-10-29
CONTACT RENEWAL (P010012/S162)Boston Scientific Corp2007-10-29
FRONTIER & FRONTIER II CRT-PS (P030035/S033)ABBOTT MEDICAL2007-10-29
PRIZM2/VITALITY (P960040/S153)Boston Scientific2007-10-29
IDENTITY,VERITY,INTEGRITY,VICTORY,ZEPHYR PACEMAKERS (P880086/S149)ABBOTT MEDICAL2007-10-29
MULTI-LINK VISION RX FAMILY OF CORONARY STENT SYSTEMS (P020047/S011)Abbott Vascular2007-10-29
NAVISTAR & EZ STEER FAMILIES OF CATHETERS (P010068/S011)Biosense Webster, Inc.2007-10-29
MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP), MODEL M00480050 (P980003/S020)Boston Scientific Corp2007-10-29
IDENTITY,INTEGRITY,VERITY,VICTORY & ZEPHYR PACEMAKERS (P880086/S153)ABBOTT MEDICAL2007-10-26
ORTHOVISC SODIUM HYALURONATE (P030019/S009)Anika Therapeutics, Inc.2007-10-26
CONTAK RENEWAL TR (P030005/S047)Guidant Corp.2007-10-26
MULTI-LINK VISION CORONARY STENT SYSTEM AND MULTI-LINK MINI VISION CORONARY STENT SYSTEM (P020047/S010)Abbott Vascular2007-10-26
ANEURX AAADVANTAGE STONE GRAFT WITH XCELERANT DELIVERY SYSTEM (P990020/S027)Medtronic Vascular2007-10-26
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S039)Cordis Corp.2007-10-26
SILICONE IOLS (P880081/S034)Johnson & Johnson Surgical Vision, Inc.2007-10-24
ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL (P040020/S005)Alcon Research, Ltd.2007-10-24
TECNIS ACRYLIC IOLS (P990080/S027)Johnson & Johnson Surgical Vision, Inc.2007-10-24
PASSIVE PLUS DX FAMILY OF LEADS (P960030/S017)ABBOTT MEDICAL2007-10-24
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S028)Med-El Corp.2007-10-24
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S011)Boston Scientific Corp2007-10-24
SENSAR ACRYLIC IOLS (P980040/S018)Johnson & Johnson Surgical Vision, Inc.2007-10-24
PROLIEVE THERMODILITATION SYSTEM (P030006/S016)Medifocus, Inc.2007-10-24
ACTICON ARTIFICIAL BOWEL SPHINCTER (P010020/S007)Boston Scientific Corp2007-10-24
PASSIVE PLUS DX FAMILY OF LEADS (P880086/S152)ABBOTT MEDICAL2007-10-24
MULTI-LINK ZETA RX CORONARY STENT SYSTEM (P970020/S049)Abbott Vascular, Inc.2007-10-24
VARIOUS FAMILIES OF PACEMAKERS & 3510 PROGRAMMER (P830045/S110)St. Jude Medical, Inc.2007-10-24
ARRAY MULTIFOCAL IOLS & REZOOM MULTIFOCAL IOLS (P960028/S024)Johnson & Johnson Surgical Vision, Inc.2007-10-24
VARIOUS FAMILIES OF ICDS & MERLIN PROGRAMMER (P910023/S158)ABBOTT MEDICAL2007-10-24
EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM (P070012)Medtronic Vascular2007-10-23
VNS THERAPY SYSTEM (P970003/S085)LivaNova USA, Inc.2007-10-23
MEDTRONIC INTERSTIM TINED LEAD MODELS 3889 & 3093 (P970004/S040)Medtronic Neuromodulation2007-10-23
GENESEARCH BREAST LYMPH NODE (P060017/S001)Janssen Diagnostics2007-10-23
OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6260 (P980049/S027)MicroPort CRM USA, Inc.2007-10-23
MITROFLOW AORTIC PERICARDIAL HEART VALVE (P060038)Corcym Canada Corp2007-10-23
DEXCOM SEVEN SYSTEM (P050012/S012)Dexcom, Inc.2007-10-22
MODEL 3120 ZOOM PROGRAMMER SYSTEM (P910077/S079)Boston Scientific2007-10-19
SAFIRE TX CATHETER (P040042/S011)Irvine Biomedical,Inc.(Ibi)2007-10-19
EPIC HF/ATLAS+HF CRT-D FAMILY OF DEVICES (P030054/S069)ABBOTT MEDICAL2007-10-19
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S029)W. L. Gore & Associates, Inc.2007-10-19
CADENCE FAMILY OF DEVICES (P910023/S156)ABBOTT MEDICAL2007-10-19
RIATA FAMILY OF LEADS (P950022/S043)ABBOTT MEDICAL2007-10-19
ZOOM LATITUDE PROGRAMMING SYSTEM (P910077/S078)Boston Scientific2007-10-18
HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT (P980043/S013)Medtronic, Inc.2007-10-18
PRIZM, VITALITY AND CONTAK RENEWAL FAMILIES OF DEVICES (P960040/S146)Boston Scientific2007-10-18
BIOGLUE SURGICAL ADHESIVE (P010003/S011)Cryolife, Inc.2007-10-18
FREESTYLE AORTIC ROOT BIOPROSTHESIS (P970031/S020)Medtronic, Inc.2007-10-18
CONTAK RENEWAL FAMILY (P010012/S153)Boston Scientific Corp2007-10-18
ANGIOSCULPT SCORING BALLOON CATHETER (P050018/S003)Spectranetics Corp.2007-10-18
MOSAIC PORCINE BIOPROSTHESIS (P990064/S020)Medtronic, Inc.2007-10-18
CORMET HIP RESURFACING SYSTEM (P050016/S001)Corin USA2007-10-18
HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT (P790007/S020)Medtronic Heart Valves2007-10-18
ACTIVA THERAPY FOR DEEP BRAIN STIMULATION (P960009/S042)Medtronic, Inc.2007-10-17
CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S042)Cordis Corp.2007-10-16
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S047)Boston Scientific Corp2007-10-16
MEDTRONIC CARELINK MONITOR PROGRAMMER MODEL 2090 (P890003/S123)Medtronic, Inc.2007-10-16
RIATA ST OPTIM LEADS AND RIATA STS OPTIM LEADS AND (P950022/S041)ABBOTT MEDICAL2007-10-16
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (P840024/S087)Cochlear Americas2007-10-16
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (P890027/S056)Cochlear Americas2007-10-16
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Track 2007 automatically

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