Atlas FDA

2007

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

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◉ Watch 2007

RecordFirmDate
ORCHESTRA PLUS PROGRAMMER & ELAVIEW 2.02 UG1 PROGRAMMING SOFTWARE (P900022/S008)MicroPort CRM USA, Inc.2007-06-29
ALL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE (P980049/S025)MicroPort CRM USA, Inc.2007-06-29
GEM III AT (P980050/S028)Medtronic, Inc.2007-06-29
THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S034)Thoratec Laboratories Corp.2007-06-28
VNS THERAPY SYSTEM (P970003/S084)LivaNova USA, Inc.2007-06-28
SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS (P910066/S023)Djo, LLC2007-06-28
LIPOSORBER LA-15 SYSTEM (P910018/S011)Kaneka Pharma America Corp.2007-06-27
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S005)Smith & Nephew, Inc.2007-06-27
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S023)W. L. Gore & Associates, Inc.2007-06-26
TENDRIL LEADS MODELS 1788 & 1782 (P960013/S033)ABBOTT MEDICAL2007-06-26
VIRTUOSO,MARQUIS,MAXIMO,INTRINSIC & ENTRUST ICDS (P980016/S101)Medtronic Cardiac Rhythm Disease Management2007-06-25
INSYNC MARQUIS/SENTRY/MAXIMO/CONCERTO CRT-ICDS (P010031/S069)Medtronic Cardiac Rhythm Disease Management2007-06-25
MERLIN PTCA CATHETER OTW AND NC PTCA CATHETER OTW (P910031/S024)Abbott Vascular Devices2007-06-22
LIBERTE MR & OTW CORONARY STENT SYSTEM (P040016/S019)Boston Scientific Scimed, Inc.2007-06-22
EXPRESS2 CORONARY STENT SYSTEM (P020009/S034)Boston Scientific Scimed, Inc.2007-06-22
PTCA CATHETERS (P860019/S216)Scimed Life Systems, Inc.2007-06-22
CONTAK RENEWAL 3 & CONTAK RENEWAL 3 RF (P010012/S150)Boston Scientific Corp2007-06-22
VITALITY HE (P960040/S145)Boston Scientific2007-06-22
SONATATI100 COCHLEAR IMPLANT (P000025/S021)Med-El Corp.2007-06-22
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR (P010021/S011)Ortho-Clinical Diagnostics, Inc.2007-06-21
MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS (P890003/S122)Medtronic, Inc.2007-06-21
MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS (P010015/S029)Medtronic, Inc.2007-06-21
COAPTITE (P040047/S003)Merz North America, Inc.2007-06-21
SPF PLUS 60/W AND SPF-PLUS 60/M (P850035/S031)Ahp Eos Buyer, Inc.2007-06-21
MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS (P980035/S074)Medtronic, Inc.2007-06-21
MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS (P990001/S031)Medtronic, Inc.2007-06-21
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S036)Cordis Corp.2007-06-20
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S035)Cordis Corp.2007-06-20
CORETHERM CATHETER (P010055/S004)Prostalund AB2007-06-19
DEFLUX INJECTABLE GEL (P000029/S033)Palette Life Sciences2007-06-18
CAPSURE VDD-2 (P890003/S121)Medtronic, Inc.2007-06-15
ATTAIN LV,CS, BIPOLAR OTW (P010015/S028)Medtronic, Inc.2007-06-15
LATITUDE PATIENT MANAGEMENT SYSTEM (P910077/S074)Boston Scientific2007-06-15
VNS THERAPY SYSTEM (P970003/S082)LivaNova USA, Inc.2007-06-15
ACRYSOF SINGLE PIECE INTRAOCULAR LENSES (P930014/S019)Alcon Laboratories, Inc.2007-06-15
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S012)Bayer Pharma AG2007-06-15
FRONTIER/FRONTIER II CRT-P PACEMAKERS (P030035/S032)ABBOTT MEDICAL2007-06-15
SUREFIX (P930039/S022)Medtronic, Inc.2007-06-15
AFFINITY,IDENTITY,VERITY,INTEGRITY,VICTORY,ZEPHYR PACEMAKERS (P880086/S147)ABBOTT MEDICAL2007-06-15
CAPSURE SP NOVUS & SENSE (P830061/S039)Medtronic Cardiac Rhythm Disease Management2007-06-15
LCS TOTAL KNEE SYSTEM (P830055/S097)Depuy, Inc.2007-06-15
CAPSURE SP,Z,Z NOVUS,SP NOVUS (P850089/S055)Medtronic Cardiac Rhythm Disease Management2007-06-15
VARIOUS FAMILIES OF CRT-ICD'S (P010031/S068)Medtronic Cardiac Rhythm Disease Management2007-06-14
VARIOUS FAMILIES OF ICD'S (P980016/S100)Medtronic Cardiac Rhythm Disease Management2007-06-14
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S005)W. L. Gore & Associates, Inc.2007-06-14
THERMATRIX OFFICE THERMOTHERAPY SYSTEM (TMX-3000) (P000043/S017)Boston Scientific Corp2007-06-14
VARIOUS FAMILIES OF PACEMAKERS (P890003/S118)Medtronic, Inc.2007-06-14
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S015)W. L. Gore & Associates, Inc.2007-06-13
INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S016)Integra Lifesciences Corp.2007-06-13
VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM (P990052/S018)Med-El Elektromedizinische Gerate GmbH2007-06-13
ACCESS HYBRITECH FREE PSA (P970038/S010)Beckman Coulter, Inc.2007-06-13
GENESIS, GENESIS RC, GENESIS XP AND THE EON NEUROSTIMULATION SYSTEMS (P010032/S020)ABBOTT MEDICAL2007-06-11
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATOR SYSTEMS (P840001/S096)Medtronic Neuromodulation2007-06-11
EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) (P900009/S025)Bioventus, LLC2007-06-11
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S001)Allergan2007-06-11
DURASEAL DURAL SEALANT SYSTEM (P040034/S009)Integra LifeSciences Corporation2007-06-11
TENDRIL & RIATA FAMILY OF LEADS (P950022/S039)ABBOTT MEDICAL2007-06-08
TENDRIL & RIATA FAMILY OF LEADS (P960013/S032)ABBOTT MEDICAL2007-06-08
SAFIRE CARDIAC ABLATION SYSTEM (P960016/S018)St Jude Medical2007-06-08
IGM ENZYME IMMUNOASSAY (P970055/S004)Diasorin2007-06-08
TRILOGY AB ACETABULAR SYSTEM (P040048/S002)Zimmer, Inc.2007-06-08
LIBERTE MONORAIL & OVER-THE-WIRE CORONARY STENT SYSTEM (P040016/S024)Boston Scientific Scimed, Inc.2007-06-08
TENDRIL & RIATA FAMILY OF LEADS (P950022/S038)ABBOTT MEDICAL2007-06-08
IGG ENZYME IMMUNOASSAY (P970054/S004)Diasorin2007-06-08
TENDRIL & RIATA FAMILY OF LEADS (P960013/S031)ABBOTT MEDICAL2007-06-08
UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (IOLS) (P880081/S033)Johnson & Johnson Surgical Vision, Inc.2007-06-07
BIOGLUE SURGICAL ADHESIVE (P010003/S010)Cryolife, Inc.2007-06-07
AFFINITY/INTEGRITY/VICTORY/ZEPHYR FAMILIES OF PACEMAKERS (P880086/S148)ABBOTT MEDICAL2007-06-07
MEDTRONIC MODEL 2090 BURBOT AND SPLAKE PROGRAMMERS (P890003/S120)Medtronic, Inc.2007-06-07
RESTYLANE INJECTABLE GEL (P040024/S008)Q-Med AB2007-06-07
ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (P960028/S021)Johnson & Johnson Surgical Vision, Inc.2007-06-07
PRIZM/VITALITY (P960040/S138)Boston Scientific2007-06-06
DEFLUX (P000029/S023)Palette Life Sciences2007-06-06
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S015)Ortho-Clinical Diagnostics, Inc.2007-06-06
ARISTA AH ABSORBABLE HEMOSTAT (P050038/S001)Davol, Inc.2007-06-06
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR (P030024/S006)Ortho-Clinical Diagnostics2007-06-06
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S022)W. L. Gore & Associates, Inc.2007-06-06
EPIC HF/ATLAS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P030054/S058)ABBOTT MEDICAL2007-06-06
MEDTRONIC VIRTUOSO ICD (MODELS D154AWG AND D154VWC) (P980016/S102)Medtronic Cardiac Rhythm Disease Management2007-06-06
MEDTRONIC CONCERTO CRT-D MODEL C154DWK (P010031/S070)Medtronic Cardiac Rhythm Disease Management2007-06-06
SWEET TIP RX/FLEXTEND (P960006/S022)Boston Scientific2007-06-06
HEALON SODIUM HYALURONATE VISCOELASTIC PRODUCTS (P810031/S034)Johnson & Johnson Surgical Vision, Inc.2007-06-06
CADENCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P910023/S141)ABBOTT MEDICAL2007-06-06
DEFLUX (P000029/S022)Palette Life Sciences2007-06-06
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S014)W. L. Gore & Associates, Inc.2007-06-06
RADIESSE (P050052/S003)Merz North America, Inc.2007-06-05
RADIESSE (P050037/S002)Merz North America, Inc.2007-06-05
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S024)W. L. Gore & Associates, Inc.2007-06-05
RESTYLANE INJECTABLE GEL (P040024/S009)Q-Med AB2007-06-05
DEFLUX INJECTABLE GEL (P000029/S031)Palette Life Sciences2007-06-01
HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P010025/S010)Hologic, Inc.2007-06-01
CADENCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) (P910023/S140)ABBOTT MEDICAL2007-06-01
BIO RAD MONOLISA ANTI-HBC IGM EIA (P060034)Bio-Rad Laboratories, Inc.2007-05-31
SEVEN PLUS CONTINOUS GLUCOSE MONITORING SYSTEM (P050012/S001)Dexcom, Inc.2007-05-31
ARISTA AH ABSORBABLE HEMOSTAT (P050038/S002)Davol, Inc.2007-05-30
PRECISION SPINAL CORD STIMULATION (SCS)SYSTEM (P030017/S020)Boston Scientific Corp2007-05-29
MONOPREP PAP TEST (P040052/S002)Hologic, Inc.2007-05-25
SJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE (P040021/S003)ABBOTT MEDICAL2007-05-25
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) (P030002/S011)Bausch & Lomb, Inc.2007-05-25
DEXCOM STS SYSTEM (P050012/S010)Dexcom, Inc.2007-05-25
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Every clearance here is in the API, with alerts when new ones post.