Atlas FDA

2014

2,485 FDA 510(k) clearances · PMA decision year

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◉ Watch 2014

RecordFirmDate
CAPSURE SENSE, SP, SP NOVUS LEADS, VITATRON CRYSTALLINE & EXCELLENCE PS LEADS (P830061/S104)Medtronic Cardiac Rhythm Disease Management2014-01-16
ADAPTA, VERSA, SENSIA IPG, ADVISA DR/DR MRI IPG; RELIA IPG (P980035/S359)Medtronic, Inc.2014-01-16
CAPSUREFIX MRI LEAD,REVO MRI IPG (P090013/S126)Medtronic, Inc.2014-01-16
APPLICATION SOFTWARE CAPSUREFIX MRI LEAD REVO MRI IPG (P090013/S123)Medtronic, Inc.2014-01-16
VITA ENHANCR II (P990001/S116)Medtronic, Inc.2014-01-16
CAPSURE FIX LEAD, CAPSUREFIX NOVUS, SUREFIX, & VITATRON CRYSTALLINE LEADS (P930039/S101)Medtronic, Inc.2014-01-16
SPRINT QUATTRO & TRANSVENE CS/SVC LEADS (P920015/S127)Medtronic, Inc.2014-01-16
ATTAIN STARFIX LEAD MODEL 4195 (P060039/S054)Medtronic, Inc.2014-01-16
SELECTSECURE LEAD (P030036/S069)Medtronic Cardiac Rhythm Disease Management2014-01-16
ATTAIN BIPOLAR OTW LEAD,CONSULTA CRT-P,LEFT VENTRICULAR PACING LEAD,SYNCRA CRT-P (P010015/S231)Medtronic, Inc.2014-01-16
EVERA S DR , S VR XT DR , XT VR . MAXIMO II , PROTECTA, XT ICD, RV, SECURA, VIRTUOSO II DR/VR ICDS/ (P980016/S453)Medtronic Cardiac Rhythm Disease Management2014-01-16
CAPSURE EPICARDIAL PACING LEAD (P950024/S057)Medtronic, Inc.2014-01-16
MYCARELINK PATIENT MONITOR, MYCARELINK READER FRU (P890003/S300)Medtronic, Inc.2014-01-16
SELECT SECURE LEAD (P030036/S068)Medtronic Cardiac Rhythm Disease Management2014-01-16
SPRINT QUATTRO LEAD & HV SPLITTER/ADAPTOR KIT (P920015/S128)Medtronic, Inc.2014-01-16
ATTAIN ABILITY LEAD (P080006/S065)Medtronic, Inc.2014-01-16
ACE HEADER, APPLICATION SOFTWARE, DEFRILLATION SUPPORT DEVICE (DISD) END CAP, EPICCARDIAL PATCH LEAD SIZILING SLEEVE UPS (P900061/S126)Medtronic Cardiac Rhythm Disease Management2014-01-16
ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S011)Abbott Vascular, Inc.2014-01-16
CAPSURE LEAD (P890003/S301)Medtronic, Inc.2014-01-16
RF MARINR MC (7FR), RF MARINR 5FR, RF CONTACTR, RF CONDUCTR, RF ENHANCR II, (P930029/S040)Medtronic, Inc.2014-01-16
APPLICATION SOFTWARE, EVERA S DR ICD, S VR ICD, XT VR DR ICD, XT VR ICD, MAXIMO II ICD, PROTECTA ICD XT ICD, RV LEAD (P970012/S094)Medtronic, Inc.2014-01-16
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S041)Vistakon, Division of Johnson & Johnson Vision Car2014-01-16
CAPSUREFIX NOVUS LEAD,VITATRON CRYSTALLINE LEAD (P930039/S102)Medtronic, Inc.2014-01-16
CAPSURE EPICARDIAL PACING LEAD (P950024/S056)Medtronic, Inc.2014-01-16
CAPSURE LEAD, CARELINK, ENCORE AND REVEAL PROGRAMMER, MONITOR READER & SOFTWARE (P890003/S298)Medtronic, Inc.2014-01-16
ATTAIN STARFIX LEAD (P060039/S055)Medtronic, Inc.2014-01-16
STARCLOSE SE VASCULAR CLOSURE SYSTEM (P050007/S031)Abbott Vascular Devices2014-01-16
ATTAIN ABILITY LEAD MODELS 4196, 4296 ,4396 (P080006/S064)Medtronic, Inc.2014-01-16
CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD (P850089/S104)Medtronic Cardiac Rhythm Disease Management2014-01-16
INCHECK PATIENT ASSISTANCE, TRANSVENE CS/SVC LEAD (P980050/S089)Medtronic, Inc.2014-01-16
PARADIGM REAL-TIME INSULIN PUMPS;PARADIGM REAL-TIME REVEL INSULIN PUMPS (P980022/S133)Medtronic Minimed2014-01-15
IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X (P050034/S012)Samsara Vision, Inc.2014-01-15
CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP (P890055/S052)Intera Oncology2014-01-15
CVX-300 EXCIMER LASER SYSTEM (P910001/S065)Spectranetics Corp.2014-01-14
SOLESTA (P100014/S009)Palette Life Sciences2014-01-14
INTEGRITY CORONARY STENT SYSTEMS (P030009/S073)Medtronic, Ireland2014-01-14
COMPLETE SE SFA/PPA VASCULAR STENT SYSTEM (P110040/S002)Medtronic Vascular2014-01-14
ELCA CORONARY ATHERECTOMY CATHETERS (P910001/S069)Spectranetics Corp.2014-01-14
COMPLETE SE ILIAC VASCULAR STENT SYSTEM (P090006/S012)Medtronic Vascular2014-01-14
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S055)Abbott Vascular2014-01-14
RESOLUTE INTEGRITY CORONARY STENT SYSTEM (P110013/S032)Medtronic Vascular2014-01-14
SPECTRANETICS LASER SHEATHS SLS (P960042/S047)Spectranetics (Philips)2014-01-14
SUPARTZ (P980044/S017)Seikagaku Corp.2014-01-14
ENDURANT STENT GRAFT SYSTEM (P100021/S031)Medtronic Vascular2014-01-14
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S085)Medtronic, Inc.2014-01-14
TALENT AAA STENT GRAFT WITH XCELERANT HYRO DELIVERY SYSTEM (P070027/S037)Medtronic Vascular2014-01-14
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT- ENDOAVITENE 5 MM (P800002/S020)C.R. Bard, Inc.2014-01-14
VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM (P100040/S015)Medtronic Vascular2014-01-14
ASSURANT COBALT ILIAC BALLON-EXPANDABLE STENT SYSTEM (P110011/S006)Medtronic, Ireland2014-01-14
ACRYSOF MONOFOCAL POSTERIOR INTRAOCULAR LENSES (P930014/S071)Alcon Laboratories, Inc.2014-01-13
REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) (P030022/S028)Smith & Nephew, Inc.2014-01-13
ACRYSOF RESTOR MULTIFOCAL POSTERIOR INTRAOCULAR LENSES (P040020/S052)Alcon Research, Ltd.2014-01-13
REFECTION CERAMIC HIP SYSTEM (RCHS) (P030022/S029)Smith & Nephew, Inc.2014-01-13
ETI-AB-EBK PLUS ASSAY (P990041/S018)DiaSorin, Inc.2014-01-10
ETI-AB-AUK PLUS ASSAY (P990042/S015)DiaSorin, Inc.2014-01-10
ETI-CORE-IGMK PLUS (P990044/S016)DiaSorin, Inc.2014-01-10
ETI-MAK-2 PLUS ASSAY (P990038/S019)DiaSorin, Inc.2014-01-10
ETI-EBK PLUS (P990043/S019)DiaSorin, Inc.2014-01-10
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S072)Med-El Corp.2014-01-10
ETI-AB-COREK PLUS ASSAY (P990045/S016)DiaSorin, Inc.2014-01-10
COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0 TEST (P050028/S038)Roche Molecular Systems, Inc.2014-01-09
COBAS AMPLICOR HCV TEST V2.0 (P000012/S047)Roche Molecular Systems, Inc.2014-01-09
PROPEL MINI SINUS IMPLANT (P100044/S013)Intersect Ent.2014-01-09
ARCHITECT AUSAB ASSAY (P050051/S025)Abbott Laboratories, Inc.2014-01-09
ACRYSOF INTRAOCULAR LENS (P930014/S070)Alcon Laboratories, Inc.2014-01-09
MYCARELINK PATIENT MONITOR (P890003/S294)Medtronic, Inc.2014-01-09
COBAS 4800 BRAF V600 MUTATION TEST (P110020/S011)Roche Molecular Systems, Inc.2014-01-09
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST (P060030/S038)Roche Molecular Systems, Inc.2014-01-09
ADAPTA, VERSA, SENSIA IPG (P980035/S356)Medtronic, Inc.2014-01-08
XIENCE PRIME EVEROLIMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM; XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYS (P110019/S059)Abbott Vascular2014-01-08
CAPSUREFIX MRI LEAD (P090013/S121)Medtronic, Inc.2014-01-08
MODEL 8880CW MEDTRONIC NEUROMODULATION CLINICIAN PROGRAMMER (P860004/S184)Medtronic, Inc.2014-01-08
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S105)Advanced Bionics2014-01-08
CAPSUREFIX NOVUS LEAD (P930039/S098)Medtronic, Inc.2014-01-08
RESURE SEALANT (P130004)Ocular Therapeutix, Inc.2014-01-08
SIENTRA SILICONE GEL BREAST IMPLANTS (P070004/S007)Tiger Aesthetics Medical, LLC2014-01-08
CAPSURE LEAD (P830061/S102)Medtronic Cardiac Rhythm Disease Management2014-01-08
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P070015/S118)Abbott Vascular, Inc.2014-01-08
XIENCE XPEDITION,XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P110019/S058)Abbott Vascular2014-01-07
VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM (P100040/S013)Medtronic Vascular2014-01-07
SELOX ST 53,SELOX ST 60,SELOX JT 45,SELOX JT 53,SETROX S 45,SETROX S53,SETROX S60,DEXTRUS 4135,DEXTRUS 4136,DETRUS 4137, (P950037/S133)Biotronik, Inc.2014-01-06
CERAMIC TRANSCEND ARTICULATION SYSTEM (P030027/S007)Microport Orthopedics, Inc.2014-01-03
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S098)Boston Scientific Corp2014-01-02
MODEL 201 PROGRAMMING WAND (P970003/S167)LivaNova USA, Inc.2014-01-02
AMS 800 URINARY CONTROL SYSTEM (P000053/S049)Boston Scientific Corp2014-01-02
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Every clearance here is in the API, with alerts when new ones post.