Atlas FDA

2006

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

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◉ Watch 2006

RecordFirmDate
INSYNC III BIVENTRICULAR PACING SYSTEM (MODEL 8041) (P010015/S016)Medtronic, Inc.2006-03-07
RIATA ST MODELS 7000, 7001, 7002, 7010, 7011, & 7012 (P950022/S027)ABBOTT MEDICAL2006-03-07
RIATA ST PASSIVE LEAD MODELS 7040, 7041, 7042,7050,7051 AND 7052 (P950022/S028)ABBOTT MEDICAL2006-03-07
TRUFILL N-BUTYL CYANOACRYLATE (NBCA) LIQUID EMBOLIC SYSTEM (P990040/S003)Cerenovus, Inc.2006-03-07
FRONTIER CRT-P (P030035/S008)ABBOTT MEDICAL2006-03-07
BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S004)Siemens Healthcare Diagnostics, Inc.2006-03-03
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (P030002/S006)Bausch & Lomb, Inc.2006-03-03
MONOPREP PAP TEST (P040052)Hologic, Inc.2006-03-03
X-SITE SUTURE-MEDIATED CLOSURE DEVICE (P020035/S002)St. Jude Medical, Inc.2006-03-03
RESTYLANE INJECTABLE GEL (P040024/S005)Q-Med AB2006-03-03
PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S026)Boston Scientific Corp2006-03-03
EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM (P020009/S025)Boston Scientific Scimed, Inc.2006-03-03
LIBERTE CORONARY STENT SYSTEM (P040016/S008)Boston Scientific Scimed, Inc.2006-03-03
ACCELEROMETER TANTALUM CAPACITOR CHANGE (P980016/S066)Medtronic Cardiac Rhythm Disease Management2006-03-02
FETAL ACOUSTIC STIMULATOR (P870025/S008)Ge Medical Systems, Inc.2006-03-02
MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEMS MODELS 3387S, 3389S DBS LEADS (P960009/S036)Medtronic, Inc.2006-03-02
MICRONY/REGENCY AND FRONTIER (P030054/S020)ABBOTT MEDICAL2006-03-02
GENERATOR AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAMILIES (P030035/S006)ABBOTT MEDICAL2006-03-02
ARTEGRAFT COLLAGEN VASCULAR GRAFT (N16837/S004)LeMaitre Vascular, Inc.2006-03-02
PROGRAMMERS TO SUPPORT VARIOUS PACEMAKERS AND DEFIBRILLATORS (P830045/S093)St. Jude Medical, Inc.2006-03-02
PERCUTANEOUS TRANSPLUMINAL CORONARY ANGIOPLASTY CATHETERS MAVERICK2 MONORAIL PTCA CATHETERS AND NC MONORAIL PTCA CATHETE (P860019/S207)Scimed Life Systems, Inc.2006-03-02
IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P910023/S092)ABBOTT MEDICAL2006-03-02
IMPLANTABLE PULSE GENERATOR, MODEL AT501 (P980035/S050)Medtronic, Inc.2006-03-02
MEDTRONIC EN-TRUST 30J/35J ICD FAMILY (P980016/S067)Medtronic Cardiac Rhythm Disease Management2006-03-02
GENERATOR AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FAMILIES (P880006/S036)St. Jude Medical, Inc.2006-03-02
TENDRILL MODEL 1488T/TC AND 1688T/TC LEADS (P960013/S017)ABBOTT MEDICAL2006-03-02
FRONTIER II DEVICE MODEL 5586 (P030035/S010)ABBOTT MEDICAL2006-03-02
MARQUIS, MAXIMO, INSYNC, ENTRUST, AND INTRINSIC FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P010031/S034)Medtronic Cardiac Rhythm Disease Management2006-03-02
MICRONY PULSE GENERATORS (P970013/S003)ABBOTT MEDICAL2006-03-02
IMPLANTABLE PACEMAKERS (P880086/S113)ABBOTT MEDICAL2006-03-02
TENDRIL MODEL 1488T/TC AND 1688T/TC LEADS (P960013/S016)ABBOTT MEDICAL2006-03-02
EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM (P020009/S024)Boston Scientific Scimed, Inc.2006-03-02
MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS) SYSTEM (P960009/S037)Medtronic, Inc.2006-03-01
DEFLUX INJECTABLE GEL (P000029/S016)Palette Life Sciences2006-03-01
GEM MODEL 7227 IMPLANTABLE DEVICE (P900061/S061)Medtronic Cardiac Rhythm Disease Management2006-02-28
INTRASTENT DOUBLE STRUT STENT (P030045/S001)Medtronic Vascular, Inc.2006-02-28
HYLAFORM (HYLAN B GEL), HYLAFORM PLUS, CAPTIQUE (P030032/S005)Genzyme Biosurgery2006-02-28
INSYNC MAQUIS, INSYNC MAXIMO, INSYNC SENTRY AND IMSYNC II MARQUIS IMPLANTABLE DEVICES (P010031/S035)Medtronic Cardiac Rhythm Disease Management2006-02-28
CARELINK MONITORS, MODELS 2490G, 2490H, 2490J (P890003/S099)Medtronic, Inc.2006-02-28
GEM DR, GEM II DR/VR, GEM III DR/VR, ONYX, MARQUIS DR/VR, MAXIMO DR/VR, INTRINSIC, INTRINSIC 30 IMPLANTABLE DEVICES (P980016/S068)Medtronic Cardiac Rhythm Disease Management2006-02-28
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (CI24R & CI24RE MODELS) (P970051/S036)Cochlear Americas2006-02-27
NUXFLEXXA (SODIUM HYALURONATE) (P010029/S001)Ferring Pharmaceuticals, Inc.2006-02-27
THERMATIX OFFICE THERMO THERAPY SYSTEM (P000043/S013)Boston Scientific Corp2006-02-27
ADATO SIL OL 5000 SILICONE OIL (P910071/S008)Bausch & Lomb2006-02-24
LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER ? SAFIRE MODEL (P960016/S014)St Jude Medical2006-02-24
QUICKSITE MODEL 1056K LEAD (P030054/S021)ABBOTT MEDICAL2006-02-24
MEDTRONIC P1501 DR ENRHYTHM IPG SYSTEM (P980035/S053)Medtronic, Inc.2006-02-22
MEDTRONIC ENTRUST MODELS D153ATG, D153DRG,D153VRC,D254ATG,D154DRG,D154VRC (P980016/S065)Medtronic Cardiac Rhythm Disease Management2006-02-22
LCS TOTAL KNEE SYSTEM (P830055/S095)Depuy, Inc.2006-02-22
THE AMPLATZER SEPTAL OCCLUDER (P000039/S015)ABBOTT MEDICAL2006-02-22
BOSTON ORTHOKERATOLOGY (OPRIFOCON A)SHAPING LENS FOR OVERNIGHT WEAR (P010062/S003)Bausch & Lomb2006-02-21
INTERSTIM (P970004/S034)Medtronic Neuromodulation2006-02-21
COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 (P000012/S007)Roche Molecular Systems, Inc.2006-02-17
AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 (P000010/S006)Roche Molecular Systems, Inc.2006-02-17
BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S003)Siemens Healthcare Diagnostics, Inc.2006-02-17
PHOTON MICRO, EPIC, ATLAS, EPIC+, AND ATLAS+ FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P910023/S095)ABBOTT MEDICAL2006-02-16
NAVISTAR DIAGNOSTIC ABLATION TIP CATHETER,QWIKSTAR DIAGNOSTIC ABLATION CATHETER (P990025/S010)Biosense Webster, Inc.2006-02-16
NAVISTAR DIAGNOSTIC ABLATION TIP CATHETER, CELSIUS DIAGNOSTIC (P950005/S020)Biosense Webster, Inc.2006-02-16
MARQUIS DR, MARQUIS VR, MAXIMO DR, MAXIMO VR, INTRINSIC 30, INTRINSIC, ENTRUST 30J/35J (P980016/S059)Medtronic Cardiac Rhythm Disease Management2006-02-16
MEDTRONIC KAPPA 400 SERIES PACEMAKER SYSTEMS (P970012/S018)Medtronic, Inc.2006-02-16
MEDTRONIC CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR SYSTEM (P010031/S029)Medtronic Cardiac Rhythm Disease Management2006-02-16
ST JUDE MEDICAL HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM (P910023/S094)ABBOTT MEDICAL2006-02-16
THERA/PRODIGY (P890003/S092)Medtronic, Inc.2006-02-16
MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW) (P910031/S023)Abbott Vascular Devices2006-02-16
SYNERGY VERSITREL, KINETRA (P840001/S083)Medtronic Neuromodulation2006-02-16
MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW) (P910031/S022)Abbott Vascular Devices2006-02-16
CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S001)Microport Orthopedics, Inc.2006-02-16
ITREL 3, SOLETRA, DCI (SYNERGY) (P960009/S033)Medtronic, Inc.2006-02-16
NAVISTAR DS DIAGNOSTIC ABLATION DEFLECTABLE TIP CATHETER, (P010068/S008)Biosense Webster, Inc.2006-02-16
PHOTON MICRO & ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) (P910023/S097)ABBOTT MEDICAL2006-02-16
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S017)CooperSurgical, Inc.2006-02-16
KAPPA 700, VITATRON, KAPPA 900, ENPULSE, SIGMA, MEDTRONIC 350 SERIES, ENRHYTHM (P980035/S049)Medtronic, Inc.2006-02-16
EASYTRAK 3 IS-1 AND LV-1 HEART FAILURE LEADS (P010012/S074)Boston Scientific Corp2006-02-16
NAVISTAR THERMOCOLD DIAGNOSTIC DEFLECTABLE TIP CATHETER, CEL (P030031/S003)Biosense Webster, Inc.2006-02-16
SCORPION/SCORPION M ABLATION CATHETER (P000020/S010)Boston Scientific Corp2006-02-16
SIEMENS MAMMOMAT NOVATION FULL FIELD DIGITAL MAMMOGRAPHY (FFDM)SYSTEM (P030010/S003)Siemens Medical Solution2006-02-15
QUICKSITE XL MODEL 1058T LEFT VENTRICULAR PACING LEAD (P030054/S018)ABBOTT MEDICAL2006-02-15
FEMCAP CONTRACEPTIVE BARRIER DEVICE (P020041/S001)Femcap Incorporated2006-02-15
MEDTRONIC PACEMAKER SYSTEMS (P890003/S096)Medtronic, Inc.2006-02-15
SETROX S STEROID-ELUTING ACTIVE-FIXATION ENDOCARDIAL PACING LEAD (MODELS SETROX S 45, SETROX S 53, AND SETROX S 60) (P950037/S042)Biotronik, Inc.2006-02-14
FISCHER IMAGING CORPORATION SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010017/S007)Hologic, Inc.2006-02-13
HIGH VISCOSITY DERMABOND MINI APPLICATOR (P960052/S011)Closure Medical Corp.2006-02-10
COOK ZENITH RENU AAA ANCILLARY GRAFT (P020018/S008)Cook, Inc.2006-02-09
PROGRAMMER TO SUPPORT VARIOUS PACEMAKERS & DEFIBRILLATORS (P830045/S092)St. Jude Medical, Inc.2006-02-08
POWERLINK SYSTEM (P040002/S002)Endologix, LLC2006-02-08
IDENTITY ADX FAMILY OF PACEMAKERS SYNCHRONCY DEVICE (P880086/S111)ABBOTT MEDICAL2006-02-08
MEDTRONIC NEUROSTIMULATION SYSTEM (ITREL 3, RESTORE, SYNERGY, SYNERGY VERSITREL SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+ (P840001/S091)Medtronic Neuromodulation2006-02-08
TACHYCARDIA DEFIBRILLATOR DEVICES (P910023/S089)ABBOTT MEDICAL2006-02-08
TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC (P960013/S015)ABBOTT MEDICAL2006-02-07
CAPSUREFIX MODELS 4568, 4067, 5068, 5067, 5568; SUREFIX MODEL 5072; SPRINT MODELS 6945, 6943; SPRINT QUATTRO MODEL 6947 (P920015/S031)Medtronic, Inc.2006-02-07
CAPSUREFIX MODELS 4568, 4067, 5068, 5067, 5568; SUREFIX MODEL 5072; SPRINT MODELS 6945, 6943; SPRINT QUATTRO MODEL 6947 (P930039/S020)Medtronic, Inc.2006-02-07
UROLOGIX TARGIS SYSTEM (P970008/S028)Urologix, LLC2006-02-06
AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM (P020024/S006)ABBOTT MEDICAL2006-02-06
AMPLATZER DUCT OCCLUDER AND AMPLATZER 180 DEGREE DELIVERY AND EXCHANGE SYSTEM (P020024/S008)ABBOTT MEDICAL2006-02-06
BIRD'S NEST VENA CAVA FILTER (P850049/S009)Cook, Inc.2006-02-03
SURGIFOAM ABSORBABLE GELATIN POWDER (P990004/S009)Ferrosan Meidcal Devices A/S2006-02-02
LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM (P000008/S008)Medtimo, Inc.2006-02-02
HER OPTION CRYOABLATION THERAPY SYSTEM (P000032/S016)CooperSurgical, Inc.2006-02-02
S660 OVER THE WIRE CORONARY STENT SYSTEM, S660 ZIPPER MX CORONARY STENT SYSTEM (P970035/S046)Medtronic, Ireland2006-02-01
MAXIMO DR/ VR MODEL 7278 AND 7232 ICD SYSTEMS (P980016/S060)Medtronic Cardiac Rhythm Disease Management2006-02-01
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Every clearance here is in the API, with alerts when new ones post.