Atlas FDA

2008

1,491 FDA 510(k) clearances · PMA decision year

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◉ Watch 2008

RecordFirmDate
CONCERTO (P010031/S105)Medtronic Cardiac Rhythm Disease Management2008-07-10
OCUCOAT (P860047/S021)Bausch & Lomb, Inc.2008-07-10
DEFLUX INJECTABLE GEL (P000029/S047)Palette Life Sciences2008-07-10
CARPENTIER-EDWARDS BIOPROSTHESIS (P870056/S029)Edwards Lifesciences, LLC2008-07-10
MONOPREP PAP TEST (P040052/S006)Hologic, Inc.2008-07-09
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S059)St. Jude Medical, Inc.2008-07-09
FRONTIER/FRONTIER II FAMILY OF CRT-PS (P030035/S044)ABBOTT MEDICAL2008-07-09
CADENCE ICD SYSTEM (P910023/S179)ABBOTT MEDICAL2008-07-09
EPIC HF CRT-D SYSTEM (P030054/S093)ABBOTT MEDICAL2008-07-09
X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM (P040001/S009)Medtronic Sofamor Danek, Inc.2008-07-09
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S165)ABBOTT MEDICAL2008-07-09
CADENCE FAMILY OF ICDS (P910023/S181)ABBOTT MEDICAL2008-07-09
EPIC HF/ATLAS + HF FAMILY OF CRT-DS (P030054/S095)ABBOTT MEDICAL2008-07-09
ELECSYS ANTI-HBS CALCHECK (P010054/S009)Roche Diagnostics Corp.2008-07-09
MICRONY FAMILY OF PACEMAKERS (P970013/S026)ABBOTT MEDICAL2008-07-09
ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S026)Cook, Inc.2008-07-09
MEDTRONIC CARELINK MONITOR AND CARDIOSIGHT READER (P890003/S141)Medtronic, Inc.2008-07-08
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2800 AND 2800TFX (P860057/S047)Edwards Lifesciences, LLC2008-07-08
CORMET HIP RESURFACING SYSTEM (P050016/S003)Corin USA2008-07-07
ARISTA AH ABSORBABLE HEMOSTAT (P050038/S006)Davol, Inc.2008-07-03
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S007)Medtronic, Inc.2008-07-03
INTERSTIM THERAPY: TORQUE WRENCH AND BOOK KIT, MODEL 3550-80 (P970004/S056)Medtronic Neuromodulation2008-07-03
ENDOTAK LEAD ADAPTOR MODEL 6952 (P910073/S072)Boston Scientific2008-07-03
BOSTON SCIENTIFIC QUANTUM MAVERICK PTCA DILATATION CATHETERS (P860019/S225)Scimed Life Systems, Inc.2008-07-03
CERAMIC TRANSCEND HIP ARTICULATION SYSTEM (P010001/S003)Ceramtec GmbH2008-07-03
CONTAK RENEWAL TR (P030005/S052)Guidant Corp.2008-07-02
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (P030022/S009)Smith & Nephew, Inc.2008-07-02
FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH (P050043/S001)Morris Innovative Research, Inc.2008-07-02
CONTAK RENEWAL/VITALITY/LIVIAN/COGNIS (P010012/S180)Boston Scientific Corp2008-07-02
VIGOR DR/SR/DISCOVER/MERIDIAN (P940031/S063)Boston Scientific2008-07-02
ARISTA AH ABSORBABLE HEMOSTAT (P050038/S007)Davol, Inc.2008-07-02
CEEON ULTRAVIOLET LIGHT-ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) (P810055/S072)Advanced Medical Optics, Inc.2008-07-02
XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015)Abbott Vascular, Inc.2008-07-02
VENTAK MINI (P910077/S088)Boston Scientific2008-07-02
METHAFILCON B SOFT HYDROPHILIC CONTACT LENSES (P850079/S043)CooperVision, Inc.2008-07-02
PRIZM/VITALITY/CONFIENT/TELIGEN (P960040/S168)Boston Scientific2008-07-02
CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S102)Medtronic Cardiac Rhythm Disease Management2008-07-02
SECURA DR/VR & MAXIMO II DR/VR (P980016/S133)Medtronic Cardiac Rhythm Disease Management2008-07-02
SPOT-LIGHT HER2 CISH KIT (P050040)Invitrogen Corporation2008-07-01
ZENITH AAA ENDOVASCULAR GRAFT WITH H&L-B ONE SHOT INTRODUCTION SYSTEM (P020018/S011)Cook, Inc.2008-07-01
MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATORS (IPG) (P980035/S099)Medtronic, Inc.2008-07-01
HANCOCK II PORCINE BIOPROSTHESIS (P980043/S016)Medtronic, Inc.2008-07-01
MOSAIC PORCINE BIOPROSTHESIS (P990064/S023)Medtronic, Inc.2008-07-01
RESTORE FAMILY OF NEUROSTIMULATOR SYSTEMS (P840001/S114)Medtronic Neuromodulation2008-07-01
VASCULAR CLOSURE DEVICE (P040044/S009)Cordis US Corporation2008-07-01
INTERSTIM II MODEL 3058 NEUROSTIMULATOR (P970004/S057)Medtronic Neuromodulation2008-06-27
TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM (P070007/S001)Medtronic Vascular2008-06-27
CADENCE FAMILY OF ICDS (P910023/S180)ABBOTT MEDICAL2008-06-27
AMS UROLUME ENDOPROSTHESIS (P920023/S025)Boston Scientific Corp2008-06-27
EPIC HF/ATLAS + HF FAMILY OF CRT-D'S (P030054/S094)ABBOTT MEDICAL2008-06-27
FRONTIER/FRONTIER II FAMILY OF CRT-P'S (P030035/S043)ABBOTT MEDICAL2008-06-27
MICRONY FAMILY OF PACEMAKERS PACEMAKER PROGRAMMER (P970013/S025)ABBOTT MEDICAL2008-06-27
EVOLENCE COLLAGEN FILLER (P070013)Colbar Lifescience , Ltd.2008-06-27
AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS (P880086/S164)ABBOTT MEDICAL2008-06-27
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S058)St. Jude Medical, Inc.2008-06-27
LATITUDE COMMUNICATOR SOFTWARE & SYSTEM SOFTWARE (P910077/S087)Boston Scientific2008-06-26
PROTÉGÉ GPS AND PROTÉGÉ RX CAROTID STENT SYSTEMS (P060001/S007)Medtronic Vascular, Inc.2008-06-26
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S009)Medtronic, Inc.2008-06-26
MEDTRONIC HALL ROTATABLE AORTIC VALVED COLLAGEN IMPREGNATED CONDUIT (P790018/S048)Medtronic Cardiac Surgery2008-06-26
DEFLUX INJECTABLE GEL (P000029/S046)Palette Life Sciences2008-06-25
ADAPTA & VERSA & SENSIA (P980035/S096)Medtronic, Inc.2008-06-25
STRATOS LV-T (P070008/S003)Biotronik, Inc.2008-06-24
ST JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S062)ABBOTT MEDICAL2008-06-24
BIOGLUE (P010003/S012)Cryolife, Inc.2008-06-24
CADENCE FAMILY OF ICDS (P910023/S175)ABBOTT MEDICAL2008-06-24
EPIC HF FAMILY CRT-DS (P030054/S088)ABBOTT MEDICAL2008-06-24
ARISTA AH ABSORBABLE HEMOSTAT (P050038/S005)Davol, Inc.2008-06-23
TECNIS ONE PIECE SOFT ACRYLIC INTRAOCULAR LENS (IOL) (P980040/S024)Johnson & Johnson Surgical Vision, Inc.2008-06-23
PRECISION SPINAL CORD STIMULATOR SYSTEM (P030017/S026)Boston Scientific Corp2008-06-23
ACRYSOF RESTOR IQ IOL (P040020/S010)Alcon Research, Ltd.2008-06-20
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S007)Smith & Nephew, Inc.2008-06-20
SEPRAFILM ADHESION BARRIER (P950034/S031)Baxter Healthcare Corporation2008-06-20
SONATA TI 100 COCHLEAR IMPLANT (P000025/S033)Med-El Corp.2008-06-20
EXPRESS2 (MONORAIL AND OVER-THE-WIRE) (P020009/S044)Boston Scientific Scimed, Inc.2008-06-19
ENTRUST, VISTUOSO, SECURA DR/VR & MAXIMO II DR/VR (P980016/S131)Medtronic Cardiac Rhythm Disease Management2008-06-19
ZENITH ENDOVASCULAR GRAFT (P020018/S025)Cook, Inc.2008-06-19
CRYSTALENS ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (AIOL), MODELS AT-45-HD100, HD500, AND HD520 (P030002/S014)Bausch & Lomb, Inc.2008-06-19
ADAPTA, VERSA & SENSIA (P980035/S094)Medtronic, Inc.2008-06-19
CADENCE ICDS (P910023/S177)ABBOTT MEDICAL2008-06-19
EPIC HF CRT-DS (P030054/S090)ABBOTT MEDICAL2008-06-19
MAVERICK, MAVERICK2, MAVERICK XL, QUANTUM MAVERICK (P860019/S226)Scimed Life Systems, Inc.2008-06-19
LIBERTE (P040016/S031)Boston Scientific Scimed, Inc.2008-06-19
TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S056)Boston Scientific Corp2008-06-19
GORE HELEX SEPTAL OCCLUDER (P050006/S008)W. L. Gore & Associates, Inc.2008-06-19
CONCERTO, CONSULTA CRT-D & MAXIMO II CRT-D (P010031/S100)Medtronic Cardiac Rhythm Disease Management2008-06-19
DEFLUX INJECTABLE GEL (P000029/S045)Palette Life Sciences2008-06-18
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEN (P980037/S024)Boston Scientific Corp2008-06-17
GUARDIAN REAL-TIME MONITOR (P980022/S027)Medtronic Minimed2008-06-16
THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR (P060019/S004)Irvine Biomedical, Inc.2008-06-13
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (P030002/S015)Bausch & Lomb, Inc.2008-06-13
BLAZER II XP CATHETERS (P020025/S019)Boston Scientific2008-06-13
RESTYLANE INJECTABLE GEL (P040024/S016)Q-Med AB2008-06-13
CHILLI II COOLED ABLATION SYSTEM (P980003/S018)Boston Scientific Corp2008-06-13
COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS (P000006/S007)Coloplast Corp.2008-06-13
BLAZER II CARDIAC ABLATION CATHETERS (P920047/S037)Boston Scientific Corp2008-06-13
CADENCE ICD SYSTEM (P910023/S178)ABBOTT MEDICAL2008-06-13
ATTAIN STARFIX MODEL 4195 LEAD (P060039)Medtronic, Inc.2008-06-13
CADENCE FAMILY OF ICD¿S (P030054/S092)ABBOTT MEDICAL2008-06-13
RESTYLANE INJECTABLE GEL (P040024/S015)Q-Med AB2008-06-13
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S034)Med-El Corp.2008-06-13
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Every clearance here is in the API, with alerts when new ones post.