Atlas FDA

2007

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

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◉ Watch 2007

RecordFirmDate
C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (P060011)Rayner Intraocular Lenses , Ltd.2007-05-03
GORE VIATORR TIPS ENDOPROSTHESIS (P040027/S004)W. L. Gore & Associates, Inc.2007-05-02
GORE VIABAHN ENDOPROSTHESIS (P040037/S005)W. L. Gore & Associates, Inc.2007-05-02
RADIESSE (P050052/S002)Merz North America, Inc.2007-05-02
RADIESSE (P050037/S001)Merz North America, Inc.2007-05-02
NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S002)Allergan2007-05-02
PERLANE INJECTABLE GEL (P040024/S006)Q-Med AB2007-05-02
ACCULINK & RX ACCULINK CAROTID STENT SYSTEMS (P040012/S026)Abbott Vascular2007-05-02
CEEON AND TECNIS POSTERIOR CHAMBER INTRAOCULAR LENS (IOLS) (P990080/S008)Johnson & Johnson Surgical Vision, Inc.2007-05-01
LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR SOFTWARE, VERSION 1.3 (MODEL 6481) (P910077/S073)Boston Scientific2007-05-01
INTRATHECAL CATHETER MODELS 8709, 8711, 8709SC, 8731SC, AND REVISION KIT 8598A (P860004/S088)Medtronic, Inc.2007-05-01
DEFLUX (P000029/S030)Palette Life Sciences2007-05-01
SURGICAL COLLAMER UV-ABSORBING POSTERIOR IOL (P990013/S009)Starr Surgical Co.2007-05-01
ACRYSOF IQ MODEL SN60WF POSTERIOR CHAMBER INTRAOCULAR LENS (P930014/S017)Alcon Laboratories, Inc.2007-04-27
MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS (P030053/S004)Mentor Corp.2007-04-27
BIO-RAD MONOLISA ANTI-HBC EIA (P060031)Bio-Rad Laboratories, Inc.2007-04-27
CARBOMEDICS CARBO-SEAL AND VALSALVA ASCENDING AORTIC PROSTHESIS (P900060/S038)Corcym S.r.l.2007-04-26
DEFLUX INJECTABLE GEL (P000029/S019)Palette Life Sciences2007-04-26
REZOOM MULTIFOCAL IOLS (P960028/S020)Johnson & Johnson Surgical Vision, Inc.2007-04-26
TECNIS ACRYLIC IOLS (P990080/S021)Johnson & Johnson Surgical Vision, Inc.2007-04-26
OSTEONICS ABC / TRIDENT SYSTEMS (P000013/S008)Howmedica Osteonics Corp.2007-04-26
REZOOM MULTIFOCAL IOLS (P960028/S019)Johnson & Johnson Surgical Vision, Inc.2007-04-26
TECNIS ACRYLIC IOLS (P990080/S022)Johnson & Johnson Surgical Vision, Inc.2007-04-26
SENSAR ACRYLIC INTRAOCULAR LENSES (IOLS) (P980040/S013)Johnson & Johnson Surgical Vision, Inc.2007-04-26
SENSAR ACRYLIC INTRAOCULAR LENSES (IOLS) (P980040/S014)Johnson & Johnson Surgical Vision, Inc.2007-04-26
VITATRON IPGS (P990001/S030)Medtronic, Inc.2007-04-25
MODEL 3100A HIGH FREQUENCY OSCILLATORY VENTILATOR (P890057/S019)ZOLL Medical Corporation2007-04-25
AMPLATZER SEPTAL OCCLUDER AND AMPLATZER TORQVUE DELIVERY AND EXCHANGE SYSTEM (P000039/S012)ABBOTT MEDICAL2007-04-25
AMPLATZER DUCT OCCLUDER (P020024/S010)ABBOTT MEDICAL2007-04-25
GORE VIABAHN ENDOPROSTHESIS (P040037/S003)W. L. Gore & Associates, Inc.2007-04-24
AB5000/BVS 5000 CIRCULATORY SUPPORT SYSTEM (P900023/S046)Abiomed Cardiovascular, Inc.2007-04-24
DAKO C-KIT PHARMDX (P040011/S001)Dako North America, Inc.2007-04-23
NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER (P040036/S002)Biosense Webster, Inc.2007-04-23
NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER (P030031/S004)Biosense Webster, Inc.2007-04-23
OXFORD MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S003)Biomet Manufacturing Corp2007-04-20
DEFLUX INJECTABLE GEL (P000029/S029)Palette Life Sciences2007-04-20
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S020)W. L. Gore & Associates, Inc.2007-04-20
DEFLUX INJECTABLE GEL (P000029/S025)Palette Life Sciences2007-04-20
DEFLUX INJECTABLE GEL (P000029/S028)Palette Life Sciences2007-04-20
DEFLUX INJECTABLE GEL (P000029/S026)Palette Life Sciences2007-04-20
DEFLUX INJECTABLE GEL (P000029/S020)Palette Life Sciences2007-04-19
DEFLUX INJECTABLE GEL (P000029/S024)Palette Life Sciences2007-04-19
FINELINE II/THINLINE II STEROX LEADS (P960004/S039)Boston Scientific2007-04-18
FREEZOR,FREEZOR XTRA & FREEZOR MAX CRYOABLATION DEVICES (P020045/S021)Medtronic Cryocath, LP2007-04-18
UROLUME URETHRAL STENT (P920023/S020)Boston Scientific Corp2007-04-17
MEDTRONIC CONCERTO MODEL C154DWK ICD (P010031/S057)Medtronic Cardiac Rhythm Disease Management2007-04-17
ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S004)Boston Scientific Corp2007-04-17
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S008)Boston Scientific Corp2007-04-17
HOUSECALL PLUS SYSTEM (P910023/S131)ABBOTT MEDICAL2007-04-17
VITROS IMMUNODIAGNOSTIC PRODUCTS HCV REAGENT PACK & CALIBRATOR (P010021/S010)Ortho-Clinical Diagnostics, Inc.2007-04-16
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK AND CALIBRATOR & CONFIRMATORY KIT (P000044/S016)Ortho-Clinical Diagnostics, Inc.2007-04-16
SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS (P990066/S028)GE Healthcare2007-04-13
POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM (P040002/S011)Endologix, LLC2007-04-13
ACUITY STEERABLE LEAD SYSTEM (P050046)Guidant Corp.2007-04-13
CONTAK RENEWAL TR FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (P030005/S043)Guidant Corp.2007-04-13
SURGIFOAM ABSORBABLE GELATIN SPONGE, SURGIFLO HEMOSTATIC MATRIX (P990004/S011)Ferrosan Meidcal Devices A/S2007-04-13
IBI THERAPY DUAL 8 ABLATION CATHETERS (P040042/S010)Irvine Biomedical,Inc.(Ibi)2007-04-13
CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S004)Cordis Corp.2007-04-13
PRECISION SPINAL CORD STIMULATOR SYSTEM (P030017/S021)Boston Scientific Corp2007-04-13
SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM (P990066/S027)GE Healthcare2007-04-13
VNS THERAPY SYSTEM (P970003/S078)LivaNova USA, Inc.2007-04-12
VENTANNA PATHWAY HER-2 (CLONE CB11) (P990081/S005)Ventana Medical Systems, Inc.2007-04-11
ON-X PROSTHETIC HEART VALVE (P000037/S012)On-X Life Technologies, Inc.2007-04-11
ENDOTEX NEXSTENT CAROTID STENT AND MONORAIL (P050025/S002)Boston Scientific2007-04-10
DEXCOM STS SYSTEM (P050012/S009)Dexcom, Inc.2007-04-10
WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P030008/S005)Alcon Laboratories, Inc.2007-04-09
WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P020050/S005)Alcon Laboratories, Inc.2007-04-09
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK & CALIBRATOR (P030026/S013)Ortho-Clinical Diagnostics, Inc.2007-04-06
PORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM (P900052/S013)Smiths Medical Asd, Inc.2007-04-05
EXPRESS2CORONARY STENT SYSTEM (P020009/S038)Boston Scientific Scimed, Inc.2007-04-04
MULTI-LINK VISION RX CORONARY STENT & MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM (P020047/S009)Abbott Vascular2007-04-04
EXPRESS2 MONORAIL (MR) & OVER-THE-WIRE (OTW) CORONARY STENT SYSTEM (P020009/S037)Boston Scientific Scimed, Inc.2007-04-04
TAXUS EXPRESS PACLITAXEL ELUTING STENT SYSTEM (P030025/S046)Boston Scientific Corp2007-04-04
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S045)Boston Scientific Corp2007-04-04
POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM (P040002/S010)Endologix, LLC2007-04-04
LIBERTE CORONARY STENT SYSTEM (P040016/S023)Boston Scientific Scimed, Inc.2007-04-04
XACT CAROTID STENT SYSTEM (P040038/S010)Abbott Vascular, Inc.2007-03-30
VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD) (P990052/S016)Med-El Elektromedizinische Gerate GmbH2007-03-30
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S018)Hologic, Inc.2007-03-29
NIRFLEX PREMOUNTED CORONARY STENT SYSTEM (P020040/S006)Medinol, Ltd.2007-03-29
ZEPHYR PULSE GENERATORS MODELS XL DR 5826,DR5820 & SR 5620 (P880086/S139)ABBOTT MEDICAL2007-03-29
POWERLINK SYSTEM WITH VISIFLEX SUREPASS DELIVERY CATHETER SYSTEM (P040002/S009)Endologix, LLC2007-03-29
ANGIOSEAL VASCULAR CLOSURE DEVICE (P930038/S049)Terumo Medical Corporation2007-03-29
STAAR SURGICAL SILICONE INTRAOCULAR LENSES (P880091/S021)Staar Surgical Co.2007-03-29
DURASEAL DURAL SEALANT SYSTEM (P040034/S008)Integra LifeSciences Corporation2007-03-29
CONTAK RENEWAL FAMILY (P010012/S149)Boston Scientific Corp2007-03-29
VITALITY FAMILY (P960040/S144)Boston Scientific2007-03-29
CONTAK RENEWAL TR FAMILY OF PULSE GENERATORS (PGS) (P030005/S042)Guidant Corp.2007-03-29
RIATA FAMILY OF LEADS (P950022/S036)ABBOTT MEDICAL2007-03-28
POSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S020)Boston Scientific Corp2007-03-28
CONTAK & RENEWAL FAMILIES OF CRT-DS (P010012/S146)Boston Scientific Corp2007-03-28
LATITUDE PATIENT MANAGEMENT SYSTEM SOFTWARE (P910077/S071)Boston Scientific2007-03-28
STAAR SURGICAL COLLAMER INTRAOCULAR LENSES (P990013/S011)Starr Surgical Co.2007-03-28
CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT (P020026/S033)Cordis Corp.2007-03-28
PRIZM & VITALITY FAMILIES OF ICDS (P960040/S141)Boston Scientific2007-03-28
FLOSEAL HEMOSTATIC MATRIX (P990009/S019)Baxter Healthcare Corp2007-03-27
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATOR & CONFIRMATORY KIT (P000044/S015)Ortho-Clinical Diagnostics, Inc.2007-03-27
VARIOUS MODELS OF PHILOS/AXIOS/PROTOS/CYLOS PG'S (P950037/S049)Biotronik, Inc.2007-03-26
VITRTUOSO MODELS D154AWG/D154VWC (P980016/S095)Medtronic Cardiac Rhythm Disease Management2007-03-26
STAAR SURGICAL SILICONE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P880091/S020)Staar Surgical Co.2007-03-26
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Every clearance here is in the API, with alerts when new ones post.