Atlas FDA

2006

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

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◉ Watch 2006

RecordFirmDate
IMPLANTABLE PACEMAKERS (P880086/S112)ABBOTT MEDICAL2006-05-02
LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM (P970043/S022)Alcon Laboratories2006-05-02
LIBERTE CORONARY STENT SYSTEM (P040016/S009)Boston Scientific Scimed, Inc.2006-05-01
TAXUS EXPRESS2 CORONARY STENT SYSTEM (P030025/S030)Boston Scientific Corp2006-05-01
VENTAK PRIZM VR, PRIZM DR, PRIZM HE VR, PRIZM HE DR, PRIZM 2 VE, PRIZM 2 DR, PRIZM AT ICDS (P960040/S091)Boston Scientific2006-05-01
CONTACK RENEWAL IS1/DR1 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P010012/S081)Boston Scientific Corp2006-05-01
LADAR 6000 EXCIMER LASER SYSTEM (P970043/S023)Alcon Laboratories2006-05-01
LADAR 6000 EXCIMER LASER SYSTEM (P970043/S019)Alcon Laboratories2006-05-01
VENTAK MINI II+ HE, MINI IV, MINI IV+ PULSE GENERATORS (P910077/S056)Boston Scientific2006-05-01
LADARVISION 4000 EXCIMER LASER SYSTEM (P970043/S020)Alcon Laboratories2006-05-01
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S029)Boston Scientific Corp2006-05-01
MICRONY PACEMAKERS (P970013/S008)ABBOTT MEDICAL2006-04-28
ENDOTAK RELIANCE FAMILY OF LEADS (P910073/S062)Boston Scientific2006-04-28
EPIC II, EPIC II+, EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILATORS (P910023/S104)ABBOTT MEDICAL2006-04-28
META AND TEMPO PACEMAKERS (P900070/S032)St. Jude Medical, Cardiac Rhythm Management Divisi2006-04-28
THINPREP IMAGING SYSTEM (P020002/S002)Hologic, Inc.2006-04-28
SOLUS,ADDVENT,SOLUS II,SYNCHRONY, PHOENIX III, TRIOLOGY, AFFINITY, INTEGRITY, ENTITY,IDENTITY, VERITY, AND VICTORY PACEM (P880086/S118)ABBOTT MEDICAL2006-04-28
FRONTIER AND FRONTIER II BIVENTRICULAR PACING SYSTEMS (P030035/S012)ABBOTT MEDICAL2006-04-28
OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD (P980049/S020)MicroPort CRM USA, Inc.2006-04-28
REGENCY, SENSOLOG III, AND DIALOG II PACEMAKERS (P880006/S041)St. Jude Medical, Inc.2006-04-28
PARAGON, PHOENIX, MULTILOG AND SENSORITHM PACEMAKERS (P830045/S098)St. Jude Medical, Inc.2006-04-28
DIGENE HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND DIGENE HYBRID CAPTURE 2 HPV DNA TEST (P890064/S018)Qiagen Gaithersburg, Inc.2006-04-28
AURORA/QUANDRA, REFLEX, SIMPLEX, AND META PACEMAKERS (P820018/S076)St. Jude Medical, Inc.2006-04-28
EPIC HF & EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.1M SOFTWARE (P030054/S025)ABBOTT MEDICAL2006-04-28
RENEWAL TR FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (P030005/S033)Guidant Corp.2006-04-26
VENTAK FAMILY OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (P960040/S119)Boston Scientific2006-04-26
CONTAK CD FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (P010012/S122)Boston Scientific Corp2006-04-26
VITALITY AND VITALITY 2 FAMILY MODELS (P960040/S117)Boston Scientific2006-04-26
VITALITY HE INTRA-CARDIAC DEFIBRILLATOR (ICD) (P010012/S123)Boston Scientific Corp2006-04-26
MERIDIAN/DISCOVERY FAMILY OF IMPLANTABLE PACEMAKERS (P940031/S052)Boston Scientific2006-04-26
CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (P960040/S120)Boston Scientific2006-04-26
MINI FAMILY OF IMPLANTABLE PACEMAKERS (P910077/S058)Boston Scientific2006-04-26
ACTROS, AXIOS, CYLOC, DROMOS, ERGOS, GEMNOS, KAIROS, KALOS, NANOS, NEOS, PHILOS, PHILOS II, PIKOS, PROTOS, TRIOS, BA03.. (P950037/S043)Biotronik, Inc.2006-04-24
ULTRAVIOLET (UV) ABSORBING AND NON-UV ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL) (P840039/S055)Bausch & Lomb, Inc.2006-04-24
PRIZM AICD SYSTEM MODELS 1850, 1853, AND 1900 (P960040/S100)Boston Scientific2006-04-24
CARDIAC AIRBAG (P980023/S021)Biotronik, Inc.2006-04-24
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM (P000008/S009)Medtimo, Inc.2006-04-24
EMDOGAIN (P930021/S009)The Straumann Company2006-04-24
BELOS,LEXOS,LUMOS,XELOS DUAL CHAMBER ICD FAMILIES (P000009/S017)Biotronik, Inc.2006-04-24
HER2 FISH PHARMDX KIT (P040005/S001)Agilent Technologies Singapore (International) Pte , Ltd.2006-04-21
KAPPA 400 FAMILY (P970012/S022)Medtronic, Inc.2006-04-21
SELECTED FAMILIES OF ICD'S (P980016/S071)Medtronic Cardiac Rhythm Disease Management2006-04-21
CONTAK RENEWAL (P010012/S120)Boston Scientific Corp2006-04-21
INSYNC FAMILIES OF CRT-ICD'S (P010031/S038)Medtronic Cardiac Rhythm Disease Management2006-04-21
INSIGNIA/NEXUS, PRIZM/VITALITY & CONTAK RENEWAL FAMILIES (P960040/S116)Boston Scientific2006-04-21
LIVEWIRE TC CARDIAC ABLATION SYSTEM (P960016/S016)St Jude Medical2006-04-21
KAPPA/SIGMA/AT500/ENPULSE/ENPULSE II PACEMAKERS (P980035/S055)Medtronic, Inc.2006-04-21
GEM III AT 7276 (P980050/S022)Medtronic, Inc.2006-04-21
MICRO-DRIVER OVER-THE-WIRE CORONARY STENT SYSTEM AND MICRO-DRIVER MX2 CORONARY STENT SYSTEM (P030009/S002)Medtronic, Ireland2006-04-21
INSYNC III (P010015/S022)Medtronic, Inc.2006-04-21
APLIGRAF (P950032/S043)Organogenesis, Inc.2006-04-21
MEDTRONIC SIGMA PACEMAKERS (P980035/S056)Medtronic, Inc.2006-04-21
CORDIS PALMAZ BALLOON-EXPANDABLE STENT FOR THE ILIAC AND RENAL ARTERIES (P890017/S014)Cordis US Corporation2006-04-21
GEM FAMILY MODEL 7227 (P900061/S063)Medtronic Cardiac Rhythm Disease Management2006-04-21
VARIOUS FAMILIES OF PACEMAKERS& MODEL 2090 PROGRAMMER (P890003/S101)Medtronic, Inc.2006-04-21
HANCOCK MODIFIED ORIFICE (MO) VALVED CONDUIT, MODEL 150 (P790007/S017)Medtronic Heart Valves2006-04-20
VITALITY FAMILY OF ICDS (P960040/S106)Boston Scientific2006-04-20
ST. JUDE MEDICAL ICDS/CRT-DS (P910023/S086)ABBOTT MEDICAL2006-04-20
FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS (P970031/S014)Medtronic, Inc.2006-04-20
ST. JUDE MEDICAL ICDS/CRT-DS (P910023/S093)ABBOTT MEDICAL2006-04-20
HANCOCK II PORCINE BIOPROSTHESIS, MODELS T505 ANF T510 (P980043/S007)Medtronic, Inc.2006-04-20
CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL 3 RF (P010012/S098)Boston Scientific Corp2006-04-20
MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310 (P990064/S012)Medtronic, Inc.2006-04-20
ICDS/CRT-DS (P030054/S016)ABBOTT MEDICAL2006-04-20
STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION (P990071/S008)Biosense Webster, Inc.2006-04-19
ETI-MAK-2 PLUS (P990038/S011)DiaSorin, Inc.2006-04-19
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P030008/S004)Alcon Laboratories, Inc.2006-04-19
CONTAK RENEWAL RF (P010012/S119)Boston Scientific Corp2006-04-14
ENDOLOGIX POWERLINK STENT GRAFT DELIVERY SYSTEM (P040002/S004)Endologix, LLC2006-04-14
BIOGLUE SURGICAL ADHESIVE (P010003/S006)Cryolife, Inc.2006-04-13
VENTAK AND CONTAK CD FAMILIES OF ICDS (P960040/S114)Boston Scientific2006-04-12
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S002)Roche Diagnostics Corp.2006-04-12
FREEZOR CARDIAC CRYOABLATION CATHETERS AND FREEZOR XTRA SURGICAL CRYOABLATION CATHETERS & CCT.2 CRYOCONSOLE SYSTEM (P020045/S017)Medtronic Cryocath, LP2006-04-12
VENTAK AND CONTAK CD FAMILIES OF ICDS (P010012/S116)Boston Scientific Corp2006-04-12
SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S021)GE Healthcare2006-04-11
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S047)Advanced Bionics2006-04-11
LUMA CERVICAL IMAGING SYSTEM (P040028/S001)Spectra Science2006-04-11
PARADIGM REAL TIME SYSTEM (P980022/S013)Medtronic Minimed2006-04-07
ON-X PROSTHETIC HEART VALVE (P000037/S011)On-X Life Technologies, Inc.2006-04-07
CONTAK RENEWAL PROGRAMMER SOFTWARE (SW) MODEL 2845 V4.33 (P010012/S085)Boston Scientific Corp2006-04-06
CCT.2 CRYOABLATION CONSOLE SYSTEM (P020045/S014)Medtronic Cryocath, LP2006-04-06
VIEWPOINT CK SYSTEM (P010018/S009)Refractec, Inc.2006-04-06
EPIC HF & ATLAS HF CRT-D'S MODEL 3650 MERLIN PATIENT CARE SYSTEM (P030054/S024)ABBOTT MEDICAL2006-04-05
PHOENIX AND PARAGON PACEMAKERS (P830045/S097)St. Jude Medical, Inc.2006-04-05
PHOTON, ATLAS/ATLAS+, EPIC/EPIC+, EPIC 2 ICD'S (P910023/S103)ABBOTT MEDICAL2006-04-05
FRONTIER/FRONTIER II CRT-P (P030035/S011)ABBOTT MEDICAL2006-04-05
VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS (P960040/S115)Boston Scientific2006-04-05
SJM ICD'S PHOTON MICRO, EPIC, EPIC +, ATLAS, ATLAS + (ICDS) (P910023/S098)ABBOTT MEDICAL2006-04-05
REGENCY PACEMAKERS (P880006/S040)St. Jude Medical, Inc.2006-04-05
VITALITY HE, RENEWAL 3 AND RENEWAL 3RF FAMILIES OF ICDS (P010012/S117)Boston Scientific Corp2006-04-05
MICRONY PACEMAKERS (P970013/S007)ABBOTT MEDICAL2006-04-05
SELECTED MODELS OF SYNCHRONY & AFFINITY FAMILIES OF PACEMAKERS (P880086/S117)ABBOTT MEDICAL2006-04-05
MEDTRONIC CAPSUREEPI PACING LEADS (P950024/S007)Medtronic, Inc.2006-04-04
QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS (P050026)Bausch + Lomb Ireland Limited2006-04-04
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR, AND HBSAG CONFIRMATORY KIT (P000044/S011)Ortho-Clinical Diagnostics, Inc.2006-04-03
CONTAK CD FAMILY (P010012/S107)Boston Scientific Corp2006-03-31
VENTAK (P960040/S112)Boston Scientific2006-03-31
VITATRON C60 DR MODEL C60A3, VITATRON C20 SR MODEL C20A3, VITATRON T60 DR MODEL T60A1, AND VITATRON T20 SR MODEL T20A1 (P990001/S024)Medtronic, Inc.2006-03-31
CONTAK CD/EASYTRAK (P010012/S113)Boston Scientific Corp2006-03-31
VARIOUS FAMILIES OF PACEMAKERS (P820003/S078)Medtronic Cardiac Rhythm Disease Management2006-03-31
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Every clearance here is in the API, with alerts when new ones post.