Atlas FDA

2010

1,845 FDA 510(k) clearances · PMA decision year

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◉ Watch 2010

RecordFirmDate
#2 BI-DIRETIONAL TORQUE WRENCH (P930035/S018)Boston Scientific2010-01-12
ETI-AB-COREK PLUS ASSAY (P990045/S009)DiaSorin, Inc.2010-01-12
ETI-CORE-IGMK PLUS ASSAY (P990044/S009)DiaSorin, Inc.2010-01-12
BIFURCATED BIPOLAR ENDOCARDIAL TINED LEAD/BIPOLAR ENDOCARDIAL LEAD/POSITIVE FIXATION PROTECTED HELIX BIPOLAR ENDOCARDIAL (P830060/S064)Boston Scientific2010-01-12
THINLINE II STEROX/THINLINE II STEROX/EZ/FINELINE II STEROX/EZ/TAPERED STYLET (P960004/S044)Boston Scientific2010-01-12
THERAPY CARDIAC ABLATION CATHETER (P040014/S012)Irvine Biomedical, Inc.2010-01-12
SELUTE PICOTIP BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/SELUTE BIPOLAR STERIOD ELUTING ENDOCARDIAL LEAD/ATRAIL J SELUTE (P950001/S020)Boston Scientific2010-01-12
LEAD CAP ACCESSORY KIT (P940008/S025)Boston Scientific2010-01-12
ETI-MAK-2 PLUS ASSAY (P990038/S012)DiaSorin, Inc.2010-01-12
SUPERIOR VENA CAVA LEAD (P890061/S017)Boston Scientific2010-01-12
THERAPY DUAL 8/THERAPY & SAFIRE TX ABLATION CATHETERS (P040042/S017)Irvine Biomedical,Inc.(Ibi)2010-01-12
ENDOTAK RELIANCE/S/ENDOTAK ENDURANCE EZ/ENDOTAK RELIANCE SG/G (P910073/S081)Boston Scientific2010-01-12
SWEET PICOTIP RX/FLEXTEND/SWEET TIP RX/FIXATION TOOL (P960006/S025)Boston Scientific2010-01-12
ETI-AB-EBK PLUS ASSAY (P990041/S011)DiaSorin, Inc.2010-01-12
MYNX VASCULAR CLOSURE DEVICE (P040044/S024)Cordis US Corporation2010-01-12
CONTAK RENEWAL/3/3 HE/3 RF/LIVIAN RF1 SE/CONTAK RENEWAL 3 AVT/COGNIS (P010012/S231)Boston Scientific Corp2010-01-12
CONTAK RENEWAL TR (P030005/S060)Guidant Corp.2010-01-12
THERAPY COOL PATH ABLATION CATHETER (P060019/S010)Irvine Biomedical, Inc.2010-01-12
ETI-EBK PLUS ASSAY (P990043/S012)DiaSorin, Inc.2010-01-12
ENDOTAK SQ PATCH LEAD/SQ ARRAY LEAD/SQ ARRAY XP/SMALL & LARGE PATCH LEADVENTAK NINI III/IV/ AICD PULSE GENERATORS (P910077/S100)Boston Scientific2010-01-12
COGNIS PULSE GENERATORS (P010012/S229)Boston Scientific Corp2010-01-12
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S002)Boston Scientific Corp2010-01-12
VENTAK PRIZM VR/DR AICD PULSE GENERATOR/DR/HE/VITALITY VR AICD PULSE GENERATOR (P960040/S212)Boston Scientific2010-01-12
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS (P860057/S064)Edwards Lifesciences, LLC2010-01-12
VITROS IMMUNDIAGNOSTICS PRODUCTS ANTI-HBS REAGENT PACK & CALIBRATOR (P000014/S019)Ortho-Clinical Diagnostics, Inc.2010-01-11
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM (P050020/S021)Abbott Laboratories2010-01-11
TRILOGY AB ACETABULAR SYSTEM (P040048/S011)Zimmer, Inc.2010-01-11
BD FOCALPOINT SLIDE PROFILER (P950009/S011)Bd Diagnostics2010-01-08
ELECSYS ANTI-HBS TEST SYSTEM (P010054/S011)Roche Diagnostics Corp.2010-01-07
BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID) (P960011/S015)Altacor , Ltd.2010-01-07
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM (P000032/S031)CooperSurgical, Inc.2010-01-07
BD 1% OVD ( 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID) (P960011/S016)Altacor , Ltd.2010-01-07
FLOSEAL HEMOSTATIC MATRIX 5 ML/10 ML KIT (P990009/S025)Baxter Healthcare Corp2010-01-07
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S027)Hologic, Inc.2010-01-07
JUVEDERM ULTRA XC AND JUVEDERM ULTRA PLUS XC (P050047/S005)Allergan2010-01-07
INSYNC CRT-P & INSYNC III CRT-P (P010015/S075)Medtronic, Inc.2010-01-06
DEMA IPG/C & T SERIES IPGS (P990001/S059)Medtronic, Inc.2010-01-06
CYPHER SIROLIMUS-ELUTING CORONARY STENT ON RAPTOR OTW DELIVERY SYSTEM/RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM (P020026/S072)Cordis Corp.2010-01-06
POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM (P040002/S024)Endologix, LLC2010-01-06
GEM II/MARQUIS/MAXIMO/II DR/VR/INTRINSIC/ENTRUST/VIRTUOSO/II DR/VR/SECURA DR/VR ICDS (P980016/S217)Medtronic Cardiac Rhythm Disease Management2010-01-06
ADAPTA/SENSIA/VERSA/RELIA (P980035/S151)Medtronic, Inc.2010-01-06
KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS (P980035/S152)Medtronic, Inc.2010-01-06
KAPPA 400 DR/SR IPG (P970012/S060)Medtronic, Inc.2010-01-06
INSYNC/INSYNC MARQUIS II/III/INSYNC PROTECT II/III/INSYNC SENTRY & MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS (P010031/S177)Medtronic Cardiac Rhythm Disease Management2010-01-06
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS (P860057/S062)Edwards Lifesciences, LLC2010-01-05
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Track 2010 automatically

Every clearance here is in the API, with alerts when new ones post.