Atlas FDA

2015

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

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◉ Watch 2015

RecordFirmDate
INOGEN, ORIGEN AND DYNAGEN CRT-D'S (P010012/S386)Boston Scientific Corp2015-04-02
ADAPTA, VERSIA, SENSIA IPG, ADVISA DR IPG, ADVISA SR MRI IPG, ADVISA DR MRI IPG AND RELIA IPG (P980035/S416)Medtronic, Inc.2015-04-02
VERSATRAX IPG (P820003/S133)Medtronic Cardiac Rhythm Disease Management2015-04-02
LOTRAFILCON A SOFT CONTACT LENSES (P010019/S037)Alcon Laboratories, Inc.2015-04-02
INOGEN, ORIGEN AND DYNAGEN ICD'S (P960040/S344)Boston Scientific2015-04-02
HEALON ENDOCOAT OPTHALMIC VISCOSURGICAL DEVICE (P110007/S006)Johnson & Johnson Surgical Vision, Inc.2015-04-02
SPRINT QUATTRO LEAD (P920015/S150)Medtronic, Inc.2015-04-02
INTERSTIM THERAPY SYSTEM (P080025/S090)Medtronic Neuromodulation2015-04-02
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S222)Medtronic, Inc.2015-04-02
REVO MRI IPG (P090013/S180)Medtronic, Inc.2015-04-02
ATTAIN ABILITY LEAD (P080006/S077)Medtronic, Inc.2015-04-02
ATAKR RADIO FREQUENCY (RF) CATHETER ABLATION SYSTEM (P930029/S050)Medtronic, Inc.2015-04-02
INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S006)Inspire Medical Systems2015-04-02
EUFLEXXA (1% SODIUM HYALURONATE) (P010029/S023)Ferring Pharmaceuticals, Inc.2015-04-02
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 (P810031/S052)Johnson & Johnson Surgical Vision, Inc.2015-04-02
SYNCHROMED INFUSION SYSTEM (P860004/S225)Medtronic, Inc.2015-04-02
PROTEGE GPS CAROTID STENT SYSTEM, PROTEGE GPS SELF-EXPANDING PERIPHERAL STENT SYSTEM (P060001/S023)Medtronic Vascular, Inc.2015-04-02
APTIMA HPV ASSAY (P100042/S005)Gen-Probe Incorporated2015-04-01
HELISTAT/ HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S060)Integra LifeSciences Corporation2015-04-01
COLLASTAT/INSTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P810006/S061)Integra LifeSciences Corporation2015-04-01
APTIMA HPV 16 18/45 GENOTYPE ASSAY (P120007/S004)Gen-Probe Incorporated2015-04-01
THORATEC HEARTMATE II LVAS (P060040/S040)ABBOTT MEDICAL2015-04-01
COLLACOTE/COLLATAPE/COLLAPLUG ABSORBABLE COLL WOUND DRESS (P840062/S045)Integra Lifesciences Corp.2015-04-01
THXID BRAF KIT (P120014/S004)bioMerieux, Inc.2015-04-01
ARCTIC FRONT/ ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER FAMILIES OF DEVICES (P100010/S047)Medtronic Cryocath, LP2015-04-01
INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE (P900033/S044)Integra Lifesciences Corp.2015-04-01
FREEZOR CARDIAC CRYO-ABLATION CATHETER FAMILIES AND THE ARTIC FRONT (P020045/S065)Medtronic Cryocath, LP2015-04-01
ON-X PROSTHETIC HEART VALVE (P000037/S030)On-X Life Technologies, Inc.2015-04-01
VASCADE VASCULAR CLOSURE SYSTEM (P120016/S012)Cardiva Medical, Inc.2015-03-31
MEDTRONIC COREVALVE (TM) SYSTEM (P130021/S011)Medtronic, Inc.2015-03-31
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S072)W. L. Gore & Associates, Inc.2015-03-31
ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE (P980037/S045)Boston Scientific Corp2015-03-31
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S111)W. L. Gore & Associates, Inc.2015-03-31
SUPARTZ (P980044/S024)Seikagaku Corp.2015-03-31
WAVELIGHT EX500 EXCIMER LASER SYSTEM (P030008/S018)Alcon Laboratories, Inc.2015-03-31
PRECISION SPECTRA SPINAL CORD STUMULATOR (SCS) SYSTEM (P030017/S206)Boston Scientific Corp2015-03-31
WAVELIGHT EX500 EXCIMER LASER SYSTEM (P020050/S020)Alcon Laboratories, Inc.2015-03-31
NIDEK EXCLAIMER LASER SYSTEM EC-5000 (P970053/S015)Nidek Co., Ltd.2015-03-30
MEDTRONIC COREVALVE SYSTEM (P130021/S010)Medtronic, Inc.2015-03-30
ADHERUS AUTOSPRAY DURAL SEALANT (P130014)Stryker Leibinger GmbH & Co KG2015-03-30
MAXIMO II, PROTECTA, PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S (P980016/S521)Medtronic Cardiac Rhythm Disease Management2015-03-30
CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, & PROTECTA XT CRT-D'S (P010031/S485)Medtronic Cardiac Rhythm Disease Management2015-03-30
SYNCHROMED INFUSION SYSTEM (P860004/S223)Medtronic, Inc.2015-03-27
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S031)Boston Scientific Corp2015-03-27
ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE (P060037/S034)Zimmer, Inc.2015-03-27
INVIVE, INTUA CRT PS (P030005/S118)Guidant Corp.2015-03-27
INTERSTIM THERAPY SYSTEM (P080025/S088)Medtronic Neuromodulation2015-03-27
RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S012)Abbott Vascular2015-03-27
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S060)Zoll Manufacturing Corporation2015-03-27
ADVANTIO, INGENIO, VITALIO, FORMIO PGS (N970003/S172)Boston Scientific Corp2015-03-27
RESTORE,ITREL AND SYNERGY SPINAL CORD STIMULATION SYSTEMS AND PISCES,SPECIFY, AND VECTRIS SPINAL CORD STIMULATION LEADS (P840001/S295)Medtronic Neuromodulation2015-03-27
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM (P960009/S221)Medtronic, Inc.2015-03-27
INTERSTIM THERAPY SYSTEM (P970004/S193)Medtronic Neuromodulation2015-03-27
JUVEDERM VOLUMA XC (P110033/S013)Allergan2015-03-26
REGENT MECHANICAL HEART VALVE (P810002/S095)ABBOTT MEDICAL2015-03-26
TACTICATH QUARTZ SET (P130026/S002)St Jude Medical2015-03-26
JUVEDERM HYALURONATE GEL IMPLANTS (P050047/S046)Allergan2015-03-26
VASCADE CLOSURE SYSTEM (P120016/S011)Cardiva Medical, Inc.2015-03-26
HELISTAT, HELITENE ABSORABLE COLLAGEN HEMOSTATIC AGENT (P850010/S059)Integra LifeSciences Corporation2015-03-26
COBAS AMPLIPREP/COBAS TAQ/MAN CYTOMEGALOVIRUS TEST (P110037/S016)Roche Molecular Systems, Inc.2015-03-26
ON-X PROSTHETIC HEART VALVE (P000037/S039)On-X Life Technologies, Inc.2015-03-26
COLLASTAT INSTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE,COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM (P810006/S060)Integra LifeSciences Corporation2015-03-26
ARCHITECT FREE PSA (LN 6C07) (P980007/S039)Abbott Laboratories2015-03-26
COLLACOTE, COLLATAPE, COLLAPLUG ABSORABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY (P840062/S044)Integra Lifesciences Corp.2015-03-26
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S075)Terumo Medical Corporation2015-03-26
INTERSTIM THERAPY SYSTEM (P970004/S192)Medtronic Neuromodulation2015-03-26
INTERSTIM THERAPY SYSTEM (P080025/S087)Medtronic Neuromodulation2015-03-26
ARCHITECT TOTAL PSA (LN 6C06) (P910007/S048)Abbott Laboratories2015-03-26
LCS TOTAL KNEE SYSTEM (P830055/S155)Depuy, Inc.2015-03-25
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S056)Medtronic2015-03-25
SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM (P080009/S005)Scott Laboratories, Inc.2015-03-25
TRANSCEND HIP ARTICULATION SYSTEM (P010001/S011)Ceramtec GmbH2015-03-25
CERAMAX CERAMIC TOTAL HIP SYSTEM (P070026/S029)DePuy Orthopaedics, Inc.2015-03-25
BELOTERO BALANCE (P090016/S014)Merz North America, Inc.2015-03-25
HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S055)Medtronic2015-03-25
ENDURANT STENT GRAFT SYSTEM, ENDURANT (II/IIS) STENT GRAFT SYSTEM, ENDURANT II AORTO-UNI-ILIAC (AUI) STENT GRAFT SYSTEM (P100021/S045)Medtronic Vascular2015-03-25
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S215)Boston Scientific Corp2015-03-25
BLAZER II XP ABLATION CATHETERS, INTELLATIP MIFI XP ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES ASSOICATED WITH CARDIAC (P020025/S068)Boston Scientific2015-03-24
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S039)ABBOTT MEDICAL2015-03-24
BLAZER II /BLAZER II HTD,BLAZER PRIME (XP/HTD) ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES (P920047/S077)Boston Scientific Corp2015-03-24
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S094)ABBOTT MEDICAL2015-03-24
GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S014)Glaukos Corporation2015-03-24
CHILLI II COOLED ABLATION SYSTEM (P980003/S057)Boston Scientific Corp2015-03-24
TRUEFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM (P990040/S020)Cerenovus, Inc.2015-03-24
EZ STEER NAV DS (P010068/S046)Biosense Webster, Inc.2015-03-23
EZ STEER NAV (P990025/S045)Biosense Webster, Inc.2015-03-23
INVIVE AND INTUA CRT-PS (P030005/S117)Guidant Corp.2015-03-23
PURE VISION (BALAFILCON A)VISIBILITY TINTED CONTACT LENS (P980006/S024)Bausch & Lomb, Inc.2015-03-23
NOVOTTF-100A SYSTEM (P100034/S012)Novocure, GmbH2015-03-23
ENLITE SENSOR (P120010/S063)Medtronic, Inc.2015-03-23
EZ STEER THERMOCOOL NAV, THERMOCOOL SF NAV (P030031/S067)Biosense Webster, Inc.2015-03-23
EZ STEER THERMOCOOL NAV (P040036/S050)Biosense Webster, Inc.2015-03-23
IMPELLA 2.5 System (P140003)Abiomed, Inc.2015-03-23
SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEMS (P080009/S004)Scott Laboratories, Inc.2015-03-23
ADVANTIO, INGENIO AND VITALIO PACEMAKERS (N970003/S171)Boston Scientific Corp2015-03-23
HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS (P850010/S058)Integra LifeSciences Corporation2015-03-20
ACCESS HYBRITECH FREE PSA REAGENT/CALIBRATOR KIT (P970038/S029)Beckman Coulter, Inc.2015-03-20
LIFE PULSE HIGH FREQUENCY VENTILATOR (P850064/S029)Bunnell, Inc.2015-03-20
CERAMAX (R) CERAMIC TOTAL HIP SYSTEM (P070026/S028)DePuy Orthopaedics, Inc.2015-03-20
AKREOS INTRAOCULAR LENS (P060022/S021)Bausch & Lomb, Inc.2015-03-20
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Every clearance here is in the API, with alerts when new ones post.