Atlas FDA

2015

2,169 FDA 510(k) clearances · PMA decision year

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◉ Watch 2015

RecordFirmDate
ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEMS. (P930029/S048)Medtronic, Inc.2015-03-05
RF CONTACTR (P930029/S047)Medtronic, Inc.2015-03-05
MEMORYSHAPE BREAST IMPLANTS (P060028/S006)Mentor Worldwide, LLC2015-03-05
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S043)Coloplast Corp.2015-03-05
BREATHTEK UBT FOR H.PYLORI KIT (P100025/S008)Meridian Bioscience, Inc.2015-03-05
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S045)Allergan2015-03-04
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S090)ABBOTT MEDICAL2015-03-04
PULSE GENERATOR-MODEL 102, PULSE DUO GENERATOR-MODEL 102R, ASPIREHC GENERATOR-MODEL 105 (P970003/S176)LivaNova USA, Inc.2015-03-04
EVERA S(DR/VR) ICD, EVERA XT (DR/VR) ICD, MAXIMO II ICD, PROTECTA (XT)ICD,SECURA ICD, VIRTUOUSO II(DR/VR) ICD (P980016/S526)Medtronic Cardiac Rhythm Disease Management2015-03-04
ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S411)Medtronic, Inc.2015-03-04
BRAVA (CRT-D/QUAD),CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D,PROTECTA XT,VIVA QUAD (S/XT),VIVA (S/XT) (P010031/S490)Medtronic Cardiac Rhythm Disease Management2015-03-04
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S042)Coloplast Corp.2015-03-04
REVO MRI IPG (P090013/S174)Medtronic, Inc.2015-03-04
INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S043)Integra Lifesciences Corp.2015-03-04
CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P (P010015/S263)Medtronic, Inc.2015-03-04
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S041)Coloplast Corp.2015-03-04
MYNX ACE VASCULAR CLOSURE DEVICE (MYNX ACE) (P040044/S062)Cordis US Corporation2015-03-03
ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S413)Medtronic, Inc.2015-03-03
CONSULTA, SYNCRA, VIVA CRT-PS (P010015/S265)Medtronic, Inc.2015-03-03
EVERA S DR, EVERA S VR, EVERA XT DR,EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS (P980016/S528)Medtronic Cardiac Rhythm Disease Management2015-03-03
SYNCHROMED II INFUSION PUMP (P860004/S222)Medtronic, Inc.2015-03-03
OCUCOAT OVD (P860047/S029)Bausch & Lomb, Inc.2015-03-03
BRAVA,BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT, VIVA S, VIVA XT CR (P010031/S492)Medtronic Cardiac Rhythm Disease Management2015-03-03
SPRINT QUATTRO LEAD (P920015/S148)Medtronic, Inc.2015-03-03
MENTOR MEMORYSHAPE BREAST IMPLANTS (P060028/S005)Mentor Worldwide, LLC2015-03-02
CAPSUREFIX MRI LEAD (P090013/S177)Medtronic, Inc.2015-03-02
CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD,SUREFIX LEAD, VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, VITATRON CRYSTALLINE ACT (P930039/S125)Medtronic, Inc.2015-03-02
CAPSURE SENSE LEAD, CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD (P830061/S118)Medtronic Cardiac Rhythm Disease Management2015-03-02
CAPSURE SP NOVUS LEAD,CAPSURE Z NOVUS LEAD (P850089/S113)Medtronic Cardiac Rhythm Disease Management2015-03-02
TRANSVENE CS/SVC LEAD (P980050/S098)Medtronic, Inc.2015-03-02
SELECTSECURE LEAD (P030036/S077)Medtronic Cardiac Rhythm Disease Management2015-03-02
M-VU ALGORITHM ENGINE (P100005/S005)Icad, Inc.2015-03-02
CAPSURE VDD 2 LEAD (P890003/S327)Medtronic, Inc.2015-03-02
ATTAIN ABILITY LEAD AND ATTAIN QUADRIPOLAR LEAD (P080006/S076)Medtronic, Inc.2015-03-02
SYNCHROMED INFUSION SYSTEM (P860004/S221)Medtronic, Inc.2015-03-02
ATTAIN BIPOLAR OTW LEAD AND ATTAIN OTW LEAD (P010015/S267)Medtronic, Inc.2015-03-02
ATTAIN STARFIX LEAD (P060039/S066)Medtronic, Inc.2015-03-02
SPRINT QUATRO LEAD,SUBCUTANEOUS LEAD (P920015/S149)Medtronic, Inc.2015-03-02
THINPREP-5000 (P950039/S026)Hologic, Inc.2015-03-02
EVERA S DR, EVERA S VR,EVERA XT DR, EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS (P980016/S527)Medtronic Cardiac Rhythm Disease Management2015-03-01
BRAVA, BRAVA QUAD, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT, VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CR (P010031/S491)Medtronic Cardiac Rhythm Disease Management2015-03-01
INOGEN, ORIGEN AND DYNAGEN CRT-DS (P010012/S385)Boston Scientific Corp2015-03-01
ADAPTA,VERSA,SENSIA IPGS, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S412)Medtronic, Inc.2015-03-01
INOGEN, ORIGEN AND DYNAGEN ICDS (P960040/S343)Boston Scientific2015-03-01
REVO MRI IPG (P090013/S175)Medtronic, Inc.2015-03-01
CONSULTA CRT-P,SYNCRA CRT-P,VIVA CRT-P (P010015/S264)Medtronic, Inc.2015-03-01
BRAVA, BRAVA QUAD, VIVA QUAD, VIVA QUAD S, VIVA QUAD XT CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S493)Medtronic Cardiac Rhythm Disease Management2015-03-01
EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD (P980016/S530)Medtronic Cardiac Rhythm Disease Management2015-03-01
ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS, ADVIA CENTAUR HBC TOTAL QUALITY CONTROL (P040004/S010)Siemens Healthcare Diagnostics2015-02-27
ENLITE SENSOR (P120010/S057)Medtronic, Inc.2015-02-27
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S095)ABBOTT MEDICAL2015-02-27
CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P (P010015/S262)Medtronic, Inc.2015-02-27
ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER (P100010/S046)Medtronic Cryocath, LP2015-02-27
ADAPTA VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG. (P980035/S410)Medtronic, Inc.2015-02-27
REVO MRI IPG (P090013/S173)Medtronic, Inc.2015-02-27
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P100041/S064)Edwards Lifesciences, LLC2015-02-27
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES (P130009/S027)Edwards Lifesciences, LLC2015-02-27
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES (P110021/S051)Edwards Lifesciences, LLC2015-02-27
EVERA S DR & VR ICD, EVERA XT DR & VR ICD, MAXIMO II ICD, PROTECTA ICD & XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S525)Medtronic Cardiac Rhythm Disease Management2015-02-27
BRAVA CRT-D; BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTCA CRT-D & XT CRT-D, VIVA QUAD (P010031/S489)Medtronic Cardiac Rhythm Disease Management2015-02-27
SIR-SPHERES MICROSPHERES (P990065/S008)Sirtex Medical, Inc.2015-02-27
INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S005)Inspire Medical Systems2015-02-27
FLOSEAL HEMOSTATIC MATRIX (P990009/S039)Baxter Healthcare Corp2015-02-26
BRAVA , QUAD , VIVA QUAD S CRT-D'S; VIVA QUAD S , QUAD XT, S VIVA S CRT-D'S (P010031/S486)Medtronic Cardiac Rhythm Disease Management2015-02-26
TACTICATH QUARTZ ABLATION CATHETER (P130026/S001)St Jude Medical2015-02-26
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT (P100022/S012)Cook Ireland, Ltd.2015-02-26
FLEXABILITY ABLATION CATHETER (P110016/S015)ABBOTT MEDICAL2015-02-26
EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, (P980016/S522)Medtronic Cardiac Rhythm Disease Management2015-02-26
SESOLOG / DIALOG / REGENCY FAMILY OF PACEMAKERS (P880006/S092)St. Jude Medical, Inc.2015-02-25
NATRELLE SILICONE-FILLED BREAST IMPLANTS (P020056/S026)Allergan2015-02-25
INTUA, INVIVE, VALITUDE, & VALITUDE X4 CRT-P'S (P030005/S116)Guidant Corp.2015-02-25
QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S281)ABBOTT MEDICAL2015-02-25
FRONTIER/FRONTIER II / ANTHEM FAMILY OF CRT-P'S (P030035/S131)ABBOTT MEDICAL2015-02-25
MEDTRONIC SYNCHROMED INFUSION SYSTEM (P860004/S205)Medtronic, Inc.2015-02-25
MINIMED 530G INSULIN PUMP (P120010/S059)Medtronic, Inc.2015-02-25
MICRONY FAMILY OF PACEMAKER (P970013/S063)ABBOTT MEDICAL2015-02-25
ENLITE GLUCOSE SENSORS (P120010/S060)Medtronic, Inc.2015-02-25
MEDTRONIC ISOMED INFUSION SYSTEM (P990034/S031)Medtronic, Inc.2015-02-25
AFFINITY /INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S253)ABBOTT MEDICAL2015-02-25
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S009)Boston Scientific Corp2015-02-25
ASCENDRA + DELIVERY SYSTEM (P130009/S025)Edwards Lifesciences, LLC2015-02-25
FORMIO, VITALIO, INGENIO, ADVANTIO, ACCOLADE, PROPONENT, ESSENTIO, & ALTRUA 2 PACEMAKERS (N970003/S170)Boston Scientific Corp2015-02-25
ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S352)ABBOTT MEDICAL2015-02-25
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S212)Boston Scientific Corp2015-02-25
HANCOCK II PROCINE BIOPROSTHETIC HEART VALVE (P980043/S048)Medtronic, Inc.2015-02-25
MOSAIC PORCINE BIOPROSTHETIC HEART VALVE (P990064/S057)Medtronic, Inc.2015-02-25
BRAVA- BRAVA QUAD , CONCERTO II , CONSULTA , MAXIMO II, PROTECTA, PROTECTA XT,VIVA QUAD, QUAD S AND IX CRT-D'S (P010031/S487)Medtronic Cardiac Rhythm Disease Management2015-02-23
TITAN INFLATABLE PENILE PROSTHESIS (P000006/S044)Coloplast Corp.2015-02-23
ADAPTA VERSA, SENSIA IPG ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S409)Medtronic, Inc.2015-02-23
BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD S (P010031/S488)Medtronic Cardiac Rhythm Disease Management2015-02-23
DYNAGEN,INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, (P010012/S384)Boston Scientific Corp2015-02-23
BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VI (P010031/S494)Medtronic Cardiac Rhythm Disease Management2015-02-23
REVO MRI IPG (P090013/S172)Medtronic, Inc.2015-02-23
CONSULTA CRT-P, SYNERA CRT-P, VIVA CRT-P (P010015/S261)Medtronic, Inc.2015-02-23
ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG (P980035/S414)Medtronic, Inc.2015-02-23
ADVISA DR IPG, ADVISA DR MRI IPG (P980035/S408)Medtronic, Inc.2015-02-23
EVERA S DR ICD,VR ICD, XT DR ICD,VR ICD, MAXIMO II ICD, PROTECTA ICD,XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD (P980016/S529)Medtronic Cardiac Rhythm Disease Management2015-02-23
EVERA S DR, VR,; EVERA XT DR, EVERA XT VR , MAXIMO II , PROTECTA , PROTECTA XT, SECURA; AND VIRTUOSO II D/RVR ICD'S (P980016/S523)Medtronic Cardiac Rhythm Disease Management2015-02-23
REVO MRI IPG (P090013/S171)Medtronic, Inc.2015-02-23
EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II D (P980016/S524)Medtronic Cardiac Rhythm Disease Management2015-02-23
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Every clearance here is in the API, with alerts when new ones post.