Atlas FDA

2019

2,638 FDA 510(k) clearances · PMA decision year

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◉ Watch 2019

RecordFirmDate
Perclose ProGlide Suture-Mediated Closure System (P960043/S105)Abbott Vascular, Inc.2019-07-30
LCS Total Knee System (P830055/S231)Depuy, Inc.2019-07-29
Avalus Bioprosthesis (P170006/S013)Medtronic, Inc.2019-07-29
NexGen LPS-Flex and LPS Mobile Bearing Knee System (P060037/S059)Zimmer, Inc.2019-07-29
Medtronic RF Ablation Catheters (P930029/S065)Medtronic, Inc.2019-07-29
Axium Neurostimulator System (P150004/S031)ABBOTT MEDICAL2019-07-29
BRIO NEUROSTIMULATION SYSTEM (P140009/S048)ABBOTT MEDICAL2019-07-29
Reply/Esprit (5th generation) Electric Hybrid Module (P950029/S123)MicroPort CRM USA, Inc.2019-07-29
SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S087)Edwards Lifesciences, LLC2019-07-29
MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S353)Medtronic, Inc.2019-07-29
ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS (P840001/S438)Medtronic Neuromodulation2019-07-29
Guardian Connect System (P160007/S020)Medtronic Minimed2019-07-29
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S153)ABBOTT MEDICAL2019-07-29
LifeVest Wearable Defibrillator (P010030/S120)Zoll Manufacturing Corporation2019-07-29
MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S414)Medtronic, Inc.2019-07-26
Visian Implantable Collamer Lens (P030016/S039)STAAR Surgical Company2019-07-26
MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S600)Medtronic, Inc.2019-07-26
MISAGO RX Self-expanding Peripheral Stent (P140002/S019)Terumo Medical Corporation2019-07-26
MitraClip NTR/XTR Clip Delivery System and Steerable Guide Catheter (P100009/S031)ABBOTT MEDICAL2019-07-26
Collamer Intraocular Lens - Alternat Environmental Monitoring Provider (P990013/S039)Starr Surgical Co.2019-07-26
Floseal hemostatic Matrix (P990009/S056)Baxter Healthcare Corp2019-07-26
MitraClip XTR Clip Delivery System (P100009/S033)ABBOTT MEDICAL2019-07-26
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S675)Medtronic Cardiac Rhythm Disease Management2019-07-26
VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S714)Medtronic Cardiac Rhythm Disease Management2019-07-26
Carbomedics Prosthetic Heart Valve (CPHV) (P900060/S060)Corcym S.r.l.2019-07-26
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S061)Boston Scientific Corp2019-07-25
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S041)Boston Scientific Corporation2019-07-25
WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S065)Boston Scientific Corp2019-07-25
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S167)Boston Scientific Corp2019-07-25
EPIC SELF-EXPANDING NITINOL STENT SYSTEM (P110035/S051)Boston Scientific Corp2019-07-25
ReSure Sealant (P130004/S007)Ocular Therapeutix, Inc.2019-07-25
BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S097)Boston Scientific Corp2019-07-25
FLEXATOME CUTTING BALLOON (P950020/S098)Boston Scientific Corp2019-07-25
Powerheart G5 Automated External Defibrillator (P160033/S002)ZOLL Medical Corporation2019-07-25
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S048)Boston Scientific Corporation2019-07-25
Infuse Bone Graft (P050053/S044)Medtronic, Inc.2019-07-25
Obalon Touch Dispenser (P160001/S043)Medtimo, Inc.2019-07-25
ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER (P980037/S075)Boston Scientific Corp2019-07-25
VisuMax Femtosecond Laser (P150040/S004)Carl Zeiss Meditec, Inc.2019-07-25
Inspire Upper Airway Stimulation System (P130008/S045)Inspire Medical Systems2019-07-25
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S031)Boston Scientific Corp2019-07-25
WALLSTENT(R) ILIAC ENDOPROSTHESIS (P940019/S056)Boston Scientific Scimed, Inc.2019-07-25
LOTUS Edge Valve System (P180029/S007)Boston Scientific Corporation2019-07-25
Eluvia Drug-Eluting Vascular Stent System (P180011/S009)Boston Scientific Corp2019-07-25
WALLSTENT ENDOPROSTHESIS (P980033/S055)Boston Scientific Corporation2019-07-25
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S050)Boston Scientific Corporation2019-07-25
ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA (P950021/S018)Siemens Healthcare Diagnostics2019-07-25
KARL STORZ Photodynamic Diagnostic (PDD) D-Light C System (P050027/S019)KARL STORZ Endoscopy-America, Inc.2019-07-25
InterStim Therapy System and Verify Evaluation System (SNM Urinary) (P970004/S293)Medtronic Neuromodulation2019-07-25
InterStim Therapy System and Verify Evaluation System (SNM Urinary and Bowel) (P080025/S188)Medtronic Neuromodulation2019-07-25
SURGIFOAM, Absorbable Gelatin Sponge U.S.P. (P990004/S034)Ferrosan Meidcal Devices A/S2019-07-24
TACTICATH QUARTZ SET (P130026/S049)St Jude Medical2019-07-24
Deep Brain Stimulation (DBS) Therapy for Epilepsy (P960009/S351)Medtronic, Inc.2019-07-24
Infuse Bone Graft and Medtronic Interbody Fusion Device (P000058/S072)Medtronic Sofamor Danek USA, Inc.2019-07-24
Onyx Liquid Embolic System (P030004/S020)Ev3 Neurovascular2019-07-24
Revanesse Versa (P160042/S007)Prollenium Medical Technologies, Inc.2019-07-24
Infuse Bone Graft (P000054/S053)Medtronic Sofamor Danek USA, Inc.2019-07-24
Propel Mini Sinus Implant (P100044/S038)Intersect Ent.2019-07-24
Eversense Continuous Glucose Monitoring System (P160048/S010)Senseonics, Incorporated2019-07-24
Spectrum Saline-Filled Breast Implants (P990075/S045)Mentor Worldwide, LLC2019-07-24
SURGICEL Absorbable Hemostats (N12159/S059)ETHICON, Inc.2019-07-23
GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S032)ETHICON, Inc.2019-07-23
Baseline Operating System Software (BOSS) for CareLink and Encore Programmers (P890003/S411)Medtronic, Inc.2019-07-23
Attain, Ability, Performa, Stability Quard MRI Lead (P080006/S138)Medtronic, Inc.2019-07-22
Amplia, Amplia Quad; Brava, Brava Quad; Claria, Claria Quad; Compia, Compia Quad; Consulta; Protecta, Protecta XT; Viva (P010031/S676)Medtronic Cardiac Rhythm Disease Management2019-07-22
CapSure VDD-2; Vitatron Brilliant S+VDD Lead (P890003/S417)Medtronic, Inc.2019-07-22
Lotus Edge Valve System (P180029/S002)Boston Scientific Corporation2019-07-22
Capsure Epicardial Pacing Lead (P950024/S087)Medtronic, Inc.2019-07-22
HV Splitter/Adoptor Kit; Sprint Quattro; Subcutaneous Lead; Transvene CS/SVC Lead (P920015/S235)Medtronic, Inc.2019-07-22
NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S058)Zimmer, Inc.2019-07-22
CapSureFix, Novus Lead (P930039/S203)Medtronic, Inc.2019-07-22
Anchoring Sleeve Kit, SelectSecure Lead (P030036/S112)Medtronic Cardiac Rhythm Disease Management2019-07-22
Evera, S, XT, DR, VR, Mirro, Primo MRI, DR, VR; Protecta VR, XT; Secura; Visia AF, MRI, VR ICD (P980016/S715)Medtronic Cardiac Rhythm Disease Management2019-07-22
Attain Bipolar OTW Lead, OTW LV Lead; Serena, Solara Quadripolar CRT-P (P010015/S415)Medtronic, Inc.2019-07-22
CapSure Sense, SP Novus; Vitaron Crystalline Lead (P830061/S174)Medtronic Cardiac Rhythm Disease Management2019-07-22
Capsure SP, Z, Novus Lead; Vitatron Impulse II Lead. (P850089/S143)Medtronic Cardiac Rhythm Disease Management2019-07-22
Inspire Upper Airway Stimulation System (P130008/S041)Inspire Medical Systems2019-07-22
NanoFLEX One Piece Collamer Intraocular Lens (CIOL) (P990013/S038)Starr Surgical Co.2019-07-19
Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P) (P070008/S105)Biotronik, Inc.2019-07-19
Visian ICL Implantable Collamer Lens (ICL) (P030016/S037)STAAR Surgical Company2019-07-19
Floseal Hemostatic Matrix (P990009/S057)Baxter Healthcare Corp2019-07-19
Pulse Generator, Permanent, Inplantable (P950037/S203)Biotronik, Inc.2019-07-19
Oxford Partial Knee System (P010014/S089)Biomet Manufacturing Corp2019-07-19
ORBERA Intragastric Balloon System (P140008/S018)Boston Scientific Corporation2019-07-19
IDEAL IMPLANT Structured Breast Implant (P120011/S016)Bimini Health Tech2019-07-19
Ceramax Ceramic Total Hip System (P070026/S063)DePuy Orthopaedics, Inc.2019-07-19
Visian Toric ICL (Implantable Collamer Lens) (P030016/S038)STAAR Surgical Company2019-07-19
Zephyr Endobronchial Valve (EBV) System (P180002/S006)Pulmonx Corporation2019-07-19
MED-EL Cochlear Implant System (P000025/S104)Med-El Corp.2019-07-19
SpF Implantable Spinal Fusion Stimulators (P850035/S055)Ahp Eos Buyer, Inc.2019-07-18
PSW 1901 U (P950037/S200)Biotronik, Inc.2019-07-18
Advisa DR, DR MRI, and SR MRI IPG, Astra S DR MRI, S SR MRI, XT DR MRI, and XT SR MRI IPG, Azure S DR MRI, S SR MRI, XT (P980035/S599)Medtronic, Inc.2019-07-18
ETI-EBK Plus Assay (P990043/S029)DiaSorin, Inc.2019-07-18
Percepta Bipolar and Quadripolar CRT-P, Serena Bipolar and Quadripolar CRT-P, Solar Bipolar and Quadripolar CRT-P (P010015/S413)Medtronic, Inc.2019-07-18
PSW 1901.U (P000009/S079)Biotronik, Inc.2019-07-18
Evera MRI DF-1, MRI, S DR, S VR, XT DR, and XT VR ICD, Mirro MRI DR and MRI VR ICD, Primo MRI DR and MRI VR ICD, Protect (P980016/S712)Medtronic Cardiac Rhythm Disease Management2019-07-18
Euclid Systems Orthokeratology (oprifocon A) and (tisilfocon A) Contact Lenses for Overnight Wear (P040029/S008)Euclid Vision Corporation2019-07-18
ETI-AB-AUK Plus Assay (P990042/S025)DiaSorin, Inc.2019-07-18
PSW 1901.U (P050023/S130)Biotronik, Inc.2019-07-18
OsteoGen Surigically Implantable Bone Growth Stimulators (P790005/S066)Ahp Eos Buyer, Inc.2019-07-18
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Every clearance here is in the API, with alerts when new ones post.