Atlas FDA

2011

2,224 FDA 510(k) clearances · PMA decision year

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◉ Watch 2011

RecordFirmDate
SYNCHROMED 2 MODEL 8637 PROGRAMMABLE DRUG INFUSION SYSTEM (P860004/S130)Medtronic, Inc.2011-07-01
COROX OTW UP STEROID-ELUTING LEAD (P050023/S014)Biotronik, Inc.2011-07-01
COROX OTW (-S) BP STEROID-ELUTING LEADS (P070008/S004)Biotronik, Inc.2011-07-01
RESTYLANE INJECTABLE GEL (P040024/S050)Q-Med AB2011-07-01
LCS TOTAL KNEE SYSTEM (P830055/S118)Depuy, Inc.2011-07-01
KENTROX SL/SL-S/RV/RV-S & LINOX S/SD/T/TD STEROID-ELUTING LEADS (P980023/S034)Biotronik, Inc.2011-07-01
XIENCE V EVROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S074)Abbott Vascular, Inc.2011-07-01
SELOX SR/ST/JT, SETROX S, AND DEXTRUS STEROID-ELUTING LEADS (P950037/S062)Biotronik, Inc.2011-07-01
CARDIOSIGHT READER (P890003/S226)Medtronic, Inc.2011-07-01
SYNCRA/CONSULTA CRT-P (P010015/S125)Medtronic, Inc.2011-07-01
ABBOTT AXSYM HBSAG & HBSAG CONFIRMATORY (P050049/S007)Abbott Laboratories, Inc.2011-07-01
ACCESS IMMUNOASSAY SYSTEMS (P980041/S013)Beckman Coulter, Inc.2011-07-01
TRIFECTA VALVE (P100029/S005)ABBOTT MEDICAL2011-07-01
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL (P020014/S034)Bayer Pharma AG2011-07-01
VISTAKON (SENOFILCON A) CONTACT LENSES/CLEAR & VISIBILITY TINTED WITH UV BLOCKER (P040045/S024)Vistakon, Division of Johnson & Johnson Vision Car2011-07-01
PARADYM CRT (P060027/S031)MicroPort CRM USA, Inc.2011-07-01
PARADYM VR/DR (P980049/S064)MicroPort CRM USA, Inc.2011-07-01
CONTAK RENEWAL TR (P030005/S078)Guidant Corp.2011-07-01
CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES (P900060/S042)Corcym S.r.l.2011-06-30
POWERLINK WITH INTUITRAK DELIVERY SYSTEM (P040002/S032)Endologix, LLC2011-06-30
CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES (P900060/S043)Corcym S.r.l.2011-06-30
GYNECARE INTERCEED ABSORBABLE ADHESION BARRIER (P880047/S016)ETHICON, Inc.2011-06-30
VERIFLEX BARE-METAL CORONARY STENT SYSTEM (P040016/S072)Boston Scientific Scimed, Inc.2011-06-30
ACRYSOF IQ RESTOR +3.0D ADD POWER POSTERIOR CHAMBER IOLS (P040020/S029)Alcon Research, Ltd.2011-06-30
FLEXTOME CUTTING BALLOON DILATATION DEVICE (P950020/S044)Boston Scientific Corp2011-06-30
CARBOMEDICS/CARBO-SEAL ASCENDING & VALSALVA/ORBIS/OPTIFORM HEART VALVES (P900060/S044)Corcym S.r.l.2011-06-30
EXPRESS2 CORONARY STENT SYSTEM (P020009/S074)Boston Scientific Scimed, Inc.2011-06-30
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S071)Boston Scientific Corp2011-06-30
NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM (P010013/S036)Hologic, Inc.2011-06-29
CAPSUREFIX MRI (P090013/S026)Medtronic, Inc.2011-06-29
ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW) (P100023/S004)Boston Scientific Corp2011-06-29
CAPSUREFIX & CRYSTALLINE ACT FIX (P930039/S055)Medtronic, Inc.2011-06-29
ACUITY STEERABLE STYLET ACCESSORY (P050046/S009)Guidant Corp.2011-06-29
QUICKFLEX U/UNIFY CRT-D (P030054/S191)ABBOTT MEDICAL2011-06-28
CURRENT ACCEL VR/DR ICD (P910023/S266)ABBOTT MEDICAL2011-06-28
ARCTIC FRONT CARDIAC CRYOABLATION CATHETER (P100010/S010)Medtronic Cryocath, LP2011-06-28
PROMOTE ACCEL CRT-D (P030035/S084)ABBOTT MEDICAL2011-06-28
TENDRIL STS (P960013/S065)ABBOTT MEDICAL2011-06-28
CAPSURE EPI UNIPOLAR/BIPOLAR LEADS (P950024/S029)Medtronic, Inc.2011-06-27
CAPSURE Z/SP NOVUS LEADS/CAPSURE/VIATRON EXCELLENCE/SS+/VITATRON IMPULSE II CAPSURE SP Z LEADS (P850089/S075)Medtronic Cardiac Rhythm Disease Management2011-06-27
ATTAIN ABILITY LEAD (P080006/S021)Medtronic, Inc.2011-06-27
ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER (P100032)Roche Diagnostics Corp.2011-06-27
CAPSURE SP NOVUS/CAPSURE/CAPSURE SENSE LEADS/VITATRON EXCELLENCE PS+/VITATRON CRYSTALLINE (P830061/S062)Medtronic Cardiac Rhythm Disease Management2011-06-27
SELECTSECURE LEAD/SLEEVE KIT (P030036/S027)Medtronic Cardiac Rhythm Disease Management2011-06-27
MARQUIS/MAXIMO ICD/INTRINSIC ICD/CAPSURE LEAD/ENTRUST ICD/VIRTUOSO ICD/MAXIMO II ICD/SECURA ICD/VIRTUOSO II ICD (P980016/S288)Medtronic Cardiac Rhythm Disease Management2011-06-27
SIGMA IPG FAMILY/MEDTRONIC 350/ENRHYTHM/AT500 SYSTEMS/ADAPTA/VERSA/SENSIA/RELIA IPGS (P980035/S211)Medtronic, Inc.2011-06-27
PRODIGY IPG/LEADS WRENCH KIT/LEADS SERVICE KIT/VITATRON BRILLIANT S+/CAPSURE VDD LEADS/CONNECTOR PORT PIN-PLUG (P890003/S219)Medtronic, Inc.2011-06-27
PIPELINE EMBOLIZATION DEVICE (P100018/S001)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2011-06-27
ATTAIN STARFIX LEAD (P060039/S024)Medtronic, Inc.2011-06-27
CAPSUREFIX NOVUS/SUREFIX/CAPSUREFIX/VITATRON PIROUET/VITATRON CRYSTALLINE ACTFIX LEADS (P930039/S050)Medtronic, Inc.2011-06-27
C & T SERIES IPG (P990001/S086)Medtronic, Inc.2011-06-27
REVO IPG & REVO MRI LEAD (P090013/S011)Medtronic, Inc.2011-06-27
PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM (P060001/S014)Medtronic Vascular, Inc.2011-06-27
CS-SVC TRANSVENE LEAD (P980050/S059)Medtronic, Inc.2011-06-27
INSYNC III CRT-P/ATTAIN OTW LEAD/BIPOLAR OTW/LV LEADS (P010015/S112)Medtronic, Inc.2011-06-27
COBAS AMPLICOR HCV TEST/COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST (P000012/S027)Roche Molecular Systems, Inc.2011-06-27
INSYNC II/III MARQUIS/MARQUIS ICD/SENTRY ICD FAMILY/MAXIMO ICD FAMILY/CONCERTO CRT-D/MAXIMO II CRT-D/CONSULTA CRT-D (P010031/S242)Medtronic Cardiac Rhythm Disease Management2011-06-27
IS-1 PORT PIN PLUG/Y ADAPTOR KIT/LEAD ADAPTOR/SPRINT LEAD/QUATTRO/QUATTRO SECURE/SUBCUTANEOUS DEFIBRILLATION/TRANSVENE (P920015/S074)Medtronic, Inc.2011-06-27
ACE HEADER/PATCH LEAD/LEAD END PIN CAP (P900061/S100)Medtronic Cardiac Rhythm Disease Management2011-06-27
AMS SPHINCTER 800 URINARY PROSTHESIS (P000053/S037)Boston Scientific Corp2011-06-24
ARCHITECT HBSAG/CONFIRMATORY (P060007/S015)Abbott Laboratories2011-06-24
COBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0 (P050028/S011)Roche Molecular Systems, Inc.2011-06-24
ARCHITECT CORE-M (P060035/S009)Abbott Laboratories2011-06-24
IMMULITE 2000 HBS AG CONFIRMATORY KIT (P010050/S011)Siemens Healthcare Diagnostics Products, Ltd.2011-06-24
ARCHITECT AUSAB (P050051/S013)Abbott Laboratories, Inc.2011-06-24
AUTODELFIA / DELFIA XPRESS HAFP TEST SYSTEM (P970037/S006)Revvity, Inc.2011-06-24
ARCHITECT CORE (P080023/S009)Abbott Laboratories2011-06-24
ARCHITECT FREE PSA (P980007/S021)Abbott Laboratories2011-06-24
ARCHITECT TOTAL PSA (P910007/S030)Abbott Laboratories2011-06-24
ARCHITECT ANTI-HCV (P050042/S013)Abbott Laboratories, Inc.2011-06-24
CERVISTA HUMAN PAPILLOMA VIRUS (HPV) HIGH RISK (HR) (P080014/S008)Hologic, Inc.2011-06-23
CERVISTA HUMAN PAPILLOMA VIRUS (HPV) 16/18 (P080015/S004)Hologic, Inc.2011-06-23
ACTIVA SC/SOLETRA/KINETRA (P960009/S118)Medtronic, Inc.2011-06-22
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S023)Vistakon, Division of Johnson & Johnson Vision Car2011-06-22
CONSULTA/SYNCRA CRT-PS (P010015/S127)Medtronic, Inc.2011-06-22
ARCHITECT FREE PSA (P980007/S017)Abbott Laboratories2011-06-22
INTERSTIM FAMILY (P970004/S115)Medtronic Neuromodulation2011-06-22
AXSYM ANTI-HCV (P970027/S014)Abbott Laboratories2011-06-22
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S059)Vistakon, Johnson & Johnson Vision Products, Inc.2011-06-22
ITREL 3 SYNERGY FAMILY (P840001/S188)Medtronic Neuromodulation2011-06-22
ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC (P100031)Roche Diagnostics Corp.2011-06-22
INTERSTIM FAMILY (P080025/S007)Medtronic Neuromodulation2011-06-22
BOSTON EQUALENS/EQUALENS II (P860022/S058)Bausch & Lomb2011-06-22
ADVISA IPG (P980035/S229)Medtronic, Inc.2011-06-22
ARCHITECT TOTAL PSA (P910007/S026)Abbott Laboratories2011-06-22
BOSTON ORTHOKERATOLOGY SHAPING LENS FOR OVERNIGHT WEAR (P010062/S009)Bausch & Lomb2011-06-22
MEDSTREAM PROGRAMMABLE INFUSION SYSTEM (P890055/S034)Intera Oncology2011-06-21
LATITUDE PACEART INTEGRATION (P910077/S115)Boston Scientific2011-06-21
CADENCE/CURRENT/FORTIFY FAMILIES OF ICDS (P910023/S257)ABBOTT MEDICAL2011-06-21
EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS (P030054/S181)ABBOTT MEDICAL2011-06-21
ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S007)Boston Scientific Corp2011-06-21
ELECSYS TOTAL PSA IMMUNOASSAY (P990056/S011)Roche Diagnostics Corp.2011-06-20
ELECSYS FREE PSA IMMUNOASSAY (P000027/S009)Roche Diagnostics Corp.2011-06-20
CONTAK RENEWAL TR PG (P030005/S077)Guidant Corp.2011-06-17
ENDOTAK LEADS (P910077/S116)Boston Scientific2011-06-17
EASYTRAK LEADS/ACUITY LEADS/CONTAK RENEWAL PG/LIVIAN ICD/COGNIS ICD (P010012/S267)Boston Scientific Corp2011-06-17
PRISMAFLEX TPE 2000 SET (P830063/S006)Vantive US Healthcare, LLC2011-06-17
ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN) (P050011/S002)Baxter Healthcare Corp2011-06-17
CONFIENT PG/VENTAK PRIZM/VITALITY PG/TELIGEN PG (P960040/S244)Boston Scientific2011-06-17
SOLETRA/KINETRA/ACTIVA PC/SC/RC (P960009/S117)Medtronic, Inc.2011-06-17
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Track 2011 automatically

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