Atlas FDA

2010

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

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◉ Watch 2010

RecordFirmDate
DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST (P890064/S022)Qiagen Gaithersburg, Inc.2010-05-17
DIGENE HYBRID CAPTURE 2 (HC2) HPV DAN TEST (P890064/S023)Qiagen Gaithersburg, Inc.2010-05-17
MEDTRONIC MODEL 2090 & 2090X CARELINK PROGRAMMER (P890003/S190)Medtronic, Inc.2010-05-14
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) (P070015/S034)Abbott Vascular, Inc.2010-05-14
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S057)Cochlear Americas2010-05-14
UROLOGIX TARGIS SYSTEM (P970008/S049)Urologix, LLC2010-05-13
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S049)Boston Scientific Corp2010-05-13
ABBOTT AXSYM ANTI-HCV (P970027/S008)Abbott Laboratories2010-05-13
DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS (P030009/S041)Medtronic, Ireland2010-05-13
HANCOCK II BIOPROSTHESIS MODEL T505 (P980043/S025)Medtronic, Inc.2010-05-13
GYNECARE THERMACHOICE 3 UTERINE BALLOON THERAPY SYSTEM (P970021/S028)Gynecare, Inc.2010-05-13
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S057)Boston Scientific Scimed, Inc.2010-05-13
MOSAIC PORCINE BIOPROSTHESIS MODEL 305 (P990064/S032)Medtronic, Inc.2010-05-13
TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS (P960013/S059)ABBOTT MEDICAL2010-05-13
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S090)Boston Scientific Corp2010-05-13
VOYAGER NC CORONARY DILATATION CATHETER (P810046/S238)Advanced Cardiovascular Systems, Inc.2010-05-13
EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S001)Boston Scientific Corporation2010-05-13
LUMAX FAMILY OF ICDS AND CRT-DS (P050023/S030)Biotronik, Inc.2010-05-13
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S088)Boston Scientific Corp2010-05-13
PASSIVE PLUS, ISOFLEX S & P, AND ISOFLEX OPTIM LEADS (P960030/S030)ABBOTT MEDICAL2010-05-13
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT (P060008/S051)Boston Scientific Corp2010-05-13
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S052)Boston Scientific Corp2010-05-13
LINOX SD AND LINOX S FAMILY OF ICD PACING LEADS (P980023/S040)Biotronik, Inc.2010-05-13
EXPRESS2 CORONARY STENT SYSTEM (P020009/S063)Boston Scientific Scimed, Inc.2010-05-13
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S050)Boston Scientific Corp2010-05-13
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S012)Boston Scientific Corp2010-05-13
STEROX S AND DEXTRUS FAMILY OF IMPLANTABLE PACEMAKER PULSE GENERATORS AND PROGRAMMERS (P950037/S080)Biotronik, Inc.2010-05-13
VERIFLEX CORONARY STENT SYSTEM (P040016/S056)Boston Scientific Scimed, Inc.2010-05-13
POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM (P040002/S028)Endologix, LLC2010-05-13
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S089)Boston Scientific Corp2010-05-13
ENTRUST/VIRTUOSO/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR ICDS (P980016/S236)Medtronic Cardiac Rhythm Disease Management2010-05-12
POWERLINK SYSTEMWITH INTUITRAK DELIVERY SYSTEM (P040002/S027)Endologix, LLC2010-05-12
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S050)W. L. Gore & Associates, Inc.2010-05-12
BIOGLUE SURGICAL ADHESIVE (P010003/S015)Cryolife, Inc.2010-05-12
ENRHYTHM IPG (P980035/S165)Medtronic, Inc.2010-05-12
DIVA PLATFORM IMPLANTABLE PULSE GENERATORS & PRO VIT APPLICATION SOFTWARE (P990001/S066)Medtronic, Inc.2010-05-12
INSYNC ICD (P010031/S195)Medtronic Cardiac Rhythm Disease Management2010-05-12
MEDTRONIC CARELINK DEVICE DATA MANAGEMENT APPLICATION (DDMA) (P890003/S188)Medtronic, Inc.2010-05-11
MODEL 2090 MEDTRONIC CARELINK PROGRAMMER (P850051/S072)Medtronic, Inc.2010-05-11
EPICARDIAL PATCH LEAD & SIZING/UPSIZING SLEEVE (P900061/S087)Medtronic Cardiac Rhythm Disease Management2010-05-11
INSYNC III (IPG) (P010015/S082)Medtronic, Inc.2010-05-11
MEDTRONIC SECURA DR/VR D224DRG/ D224VRC, MAXIMO DR/VR D284DRG/ D284VRC, VIRTUOSO II DR/VR D274DRG/ D274VRC (P980016/S234)Medtronic Cardiac Rhythm Disease Management2010-05-11
LEGEND PLUS FAMILY OF PACEMAKERS (P930022/S011)Medtronic, Inc.2010-05-11
VITATRON (P990001/S064)Medtronic, Inc.2010-05-11
TAXUS LIBERTE OTW & TAXUS LIBERTE ATOM OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S045)Boston Scientific Corp2010-05-11
EXPRESS2 OTW CORONARY STENT SYSTEM (P020009/S061)Boston Scientific Scimed, Inc.2010-05-11
MEDTRONIC CONSULTA CRT-D D224TRK, MAXIMO 2 CRT-D D284TRK, CONCERTO 2 D274TRK IMPLANTSBLE CARDIOVERTER DEFIBRILLATORS (P010031/S193)Medtronic Cardiac Rhythm Disease Management2010-05-11
VERIFLEX OTW BARE-METAL CORONARY STENT SYSTEM (P040016/S054)Boston Scientific Scimed, Inc.2010-05-11
TAXUS EXPRESS2 CORONARY STENT SYSTEM/TAXUS EXPRESS2 ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P030025/S085)Boston Scientific Corp2010-05-11
INSYNC II/III MARQUIS/INSYNC II/III PROTECT/INSYNC SENTRY/MAXIMO ICDS/CONCERTO/II/MAXIMO II/CONSULTA CRT-DS (P010031/S191)Medtronic Cardiac Rhythm Disease Management2010-05-11
KAPPA 400 DR/SR IPG (P970012/S065)Medtronic, Inc.2010-05-11
PRODIGY/THERA I IPG (P890003/S186)Medtronic, Inc.2010-05-11
SIGMA/MEDTRONIC 350 SERIES/ENRHYTHM IPG/ADAPTA/SENSIA/RELIA/VERSA (P980035/S161)Medtronic, Inc.2010-05-11
RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS (P980016/S232)Medtronic Cardiac Rhythm Disease Management2010-05-11
QUANTUM MAVERICK OTW/APEX OTW/MAVERICK OTW/MAVERICK XL MONORAIL PTCA DILATATION CATHETERS (P860019/S252)Scimed Life Systems, Inc.2010-05-11
DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR (P820003/S093)Medtronic Cardiac Rhythm Disease Management2010-05-11
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S010)Boston Scientific Corp2010-05-11
CSS-SVC TRANSVENE LEAD (P980050/S047)Medtronic, Inc.2010-05-11
QUICKFLEX U MODEL 1258T LEAD (P030054/S130)ABBOTT MEDICAL2010-05-10
KRONOS LV-T AND LUMAX 300/340 & 500/540 HF/HF-T (P050023/S024)Biotronik, Inc.2010-05-07
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S010)ABBOTT MEDICAL2010-05-07
FORTIFY DR / VR ICD SYSTEMS (P910023/S226)ABBOTT MEDICAL2010-05-07
UNIFY CRT-D SYSTEM (P030054/S141)ABBOTT MEDICAL2010-05-07
EVIA/ENTOVIS PULSE GENERATORS (P070008/S011)Biotronik, Inc.2010-05-07
EVIA / ENTOVIS & VARIOUS OTHER PULSE GENERATORS (P950037/S072)Biotronik, Inc.2010-05-07
EVIA/ENTOVIS PULSE GENERATORS (P000009/S035)Biotronik, Inc.2010-05-07
VASCULAR SOLUTIONS DUETT SEALING DEVICE (P990037/S030)Vascular Solutions, Inc.2010-05-07
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S098)Boston Scientific Corp2010-05-06
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S019)Coloplast Corp.2010-05-06
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S049)W. L. Gore & Associates, Inc.2010-05-05
PERCLOSE AT 6F SUTURE-MEDIATED CLOSURE SYSTEM & THE PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM (P960043/S071)Abbott Vascular, Inc.2010-05-05
MYNX VASCULAR CLOSURE DEVICE (P040044/S031)Cordis US Corporation2010-05-04
ST JUDE MEDICAL, MERLIN PSA EX3100 SYSTEM (P030054/S146)ABBOTT MEDICAL2010-05-03
CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR (P850079/S047)CooperVision, Inc.2010-05-03
RX ACCULINK CAROTID STENT SYSTEM (P040012/S031)Abbott Vascular2010-04-30
HEARTMATE II (P060040/S009)ABBOTT MEDICAL2010-04-30
CONCERTO II/CONSULTA CRT-D/MAXIMO II CRT-D/CONCERTO CRT-D (P010031/S194)Medtronic Cardiac Rhythm Disease Management2010-04-30
ACTIVA IMPLANTABLE NEUROSTIMULATORS (P960009/S079)Medtronic, Inc.2010-04-30
ENTRUST/SECURA DR/VR/MAXIMO II DR/VR/VIRTUOSO II DR/VIRTUOSO/VIRTUOSO II VR ICDS (P980016/S235)Medtronic Cardiac Rhythm Disease Management2010-04-30
ENRHYTHM IPG/ADAPTA/VERSA/SENIA IPG/RELIA IPG (P980035/S164)Medtronic, Inc.2010-04-30
X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S016)Medtronic Sofamor Danek, Inc.2010-04-30
RESTORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS (P840001/S150)Medtronic Neuromodulation2010-04-30
LUMAX 540 VR-T DX ICD (P050023/S029)Biotronik, Inc.2010-04-30
TALENT THORACIC GRAFT SYSTEM (P070007/S017)Medtronic Vascular2010-04-30
VISTAKON (ETAFILCON A) CONTACT LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER (N18033/S046)Vistakon, Johnson & Johnson Vision Products, Inc.2010-04-30
MYNX VASCULAR CLOSURE DEVICE (P040044/S030)Cordis US Corporation2010-04-30
VISTAKON (SENOFILCON A) CONTACTS LENSES, CLEAR & VISIBILITY TINTED WITH UV BLOCKER (P040045/S013)Vistakon, Division of Johnson & Johnson Vision Car2010-04-30
LUMAX 540 VR-T DX ICDS (P950037/S078)Biotronik, Inc.2010-04-30
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) (P030002/S022)Bausch & Lomb, Inc.2010-04-30
INTERSTIM IMPLANTABLE NEUROSTIMULATOR (P970004/S084)Medtronic Neuromodulation2010-04-30
UROLOGIX TARGIS SYSTEM (P970008/S048)Urologix, LLC2010-04-30
MEDTRONIC ACTIVA PARKINSON¿S CONTROL THERAPY (P960009/S080)Medtronic, Inc.2010-04-30
ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER (P090007)Roche Diagnostics Corp.2010-04-29
TALENT ABDOMINAL STENT GRAFT SYSTEM (P070027/S015)Medtronic Vascular2010-04-29
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER (P090008)Roche Diagnostics Corp.2010-04-29
SITUS OTW UW28D LEADS (P060027/S022)MicroPort CRM USA, Inc.2010-04-29
SITUS OTW UW28D LEADS (P020030/S006)MicroPort CRM USA, Inc.2010-04-29
ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER (P090009)Roche Diagnostics Corp.2010-04-29
MYNX VASCULAR CLOSURE DEVICE (P040044/S029)Cordis US Corporation2010-04-28
CAPSURE/CAPSURE Z NOVUS/STERX TIP PACING LEAD (VENTRICULAR)/VITATRON EXCELLENCE S+/EXCELLENCE SS+/IMPULSE/IMPULSE II (P850089/S065)Medtronic Cardiac Rhythm Disease Management2010-04-28
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Track 2010 automatically

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