Atlas FDA

2025

2,222 FDA 510(k) clearances · PMA decision year

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◉ Watch 2025

RecordFirmDate
RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™) (P920047/S136)Boston Scientific Corp2025-03-31
RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™);RHYTHMIA HDx™ (P150005/S087)Boston Scientific Corp2025-03-31
RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™); Rhythmia HDx™ Ablation Connection Box (Maestro™) (P020025/S145)Boston Scientific2025-03-31
Thoraflex™ Hybrid (P210006/S010)Vascutek, Ltd.2025-03-28
GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S107)W. L. Gore & Associates, Inc.2025-03-28
GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S168)W. L. Gore & Associates, Inc.2025-03-28
Senza HFX iQ System (P130022/S068)Nevro Corporation2025-03-28
STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR (P990071/S066)Biosense Webster, Inc.2025-03-28
VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103 (P970003/S246)LivaNova USA, Inc.2025-03-27
RHA® Redensity , RHA®2, RHA®3, RHA®4, RHA® Redensity Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi (P170002/S040)Teoxane S.A.2025-03-27
7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S112)Medtronic Cryocath, LP2025-03-27
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S203)Medtronic, Inc.2025-03-27
cobas HPV TEST (P100020/S062)Roche Molecular Systems, Inc.2025-03-27
MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) (P140017/S030)Medtronic, Inc.2025-03-27
ARCTIC FRONT CRYOCATHETER SYSTEM (P100010/S150)Medtronic Cryocath, LP2025-03-27
OPTIMIZER Smart, OPTIMIZER Smart Mini, OPTIMIZER Lite (P180036/S033)Impulse Dynamics (Usa), Inc.2025-03-27
cobas HPV for use on the cobas 6800/8800 Systems (P190028/S019)Roche Molecular Systems, Inc.2025-03-27
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM (P160048/S029)Senseonics, Incorporated2025-03-27
Amplatzer™ Amulet™ Left Atrial Appendage Occluder (P200049/S011)ABBOTT MEDICAL2025-03-27
Amplatzer™ Septal Occluder; Amplatzer™ Amulet™ Left Atrial Appendage Occluder (P000039/S082)ABBOTT MEDICAL2025-03-27
Pipeline Flex Embolization Device; Pipeline Flex Embolization Device with Shield Technology (Pipeline™ Shield) (P100018/S050)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2025-03-27
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump) (P240006/S004)Biosense Webster, Inc.2025-03-26
IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S036)Medtronic Vascular, Inc.2025-03-26
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated (P140010/S087)Medtronic, Inc.2025-03-26
TOPS™ System (P220002/S006)Premia Spine, Ltd.2025-03-25
Biofinity Sphere (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S185)CooperVision, Inc.2025-03-25
Optune® (P100034/S039)Novocure, GmbH2025-03-25
Crimper (P140031/S185)Edwards Lifesciences, LLC2025-03-25
Exablate Model 4000 Type 1.0 and 1.1 Systems (“Exablate Neuro”) (P150038/S026)Insightec2025-03-25
Paradise Ultrasound Renal Denervation System; Paradise Catheter (P220023/S008)Recor Medical, Inc.2025-03-25
Crimper (P200015/S062)Edwards Lifesciences, LLC2025-03-25
Prospera SCS System, Resilience Surgical Lead, Embrace One (P210037/S006)Biotronik Nro, Inc.2025-03-24
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S005)Alcon Research, LLC2025-03-24
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S005)Alcon Research, LLC2025-03-24
AcrySof Posterior Chamber Intraocular Lenses (P930014/S154)Alcon Laboratories, Inc.2025-03-21
TOPS™ System (P220002/S007)Premia Spine, Ltd.2025-03-21
SURGICEL® Absorbable Hemostats and SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S102)ETHICON, Inc.2025-03-21
AccelStim (P210035/S003)Orthofix US, LLC2025-03-21
Symplicity Spyral Multi-Electrode Renal Denervation Catheter (P220026/S013)Medtronic, Inc.2025-03-21
Boston Scientific Cardiac Cryoablation System (P220032/S010)Boston Scientific Corporation2025-03-21
Medtronic Selectsecure Lead Model 3830 (P030036/S151)Medtronic Cardiac Rhythm Disease Management2025-03-20
Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit (P220020/S004)Sirtex Medical, Inc.2025-03-20
Medtronic Attain Ability Model 4196 Lead (P080006/S190)Medtronic, Inc.2025-03-20
Aurora EV-ICD System (P220012/S043)Medtronic, Inc.2025-03-20
Activitrax Models 8400, 8402, 8403 (P850051/S085)Medtronic, Inc.2025-03-20
Atellica IM Anti-HBe2 (aHBe2) (P200017/S003)Siemens Healthcare Diagnostics, Inc.2025-03-20
Medtronic PCD Tachyarrhythmia Control System (P900061/S175)Medtronic Cardiac Rhythm Disease Management2025-03-20
Revo MRI Surescan IPG and Pacing System (P090013/S336)Medtronic, Inc.2025-03-20
Capsure SP, Capsure, Capsure 2 Leads, Excellence S, Impulse, Impulse II Excellence SS, Leads (P850089/S171)Medtronic Cardiac Rhythm Disease Management2025-03-20
Cologuard® (P130017/S061)Exact Sciences Corporation2025-03-20
Synergyst II Pulse Generator Models 7070 & 7071 (P890003/S475)Medtronic, Inc.2025-03-20
Model 5071 Lead (P120017/S038)Medtronic, Inc.2025-03-20
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 (P930039/S270)Medtronic, Inc.2025-03-20
RADIESSE Injectable Implant; RADIESSE Hands; RADIESSE (+) Lidocaine Dermal Filler; RADIESSE (+) Jawline (P050052/S166)Merz North America, Inc.2025-03-20
Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators (P980016/S918)Medtronic Cardiac Rhythm Disease Management2025-03-20
Medtronic.Kappa 400 Series Pacemakers (P970012/S101)Medtronic, Inc.2025-03-20
Steroid TIP(TM) Model 4503 & 4003 Transvenous Pacing (P830061/S230)Medtronic Cardiac Rhythm Disease Management2025-03-20
Diva Platform Implantable Pulse Generators; PRO VIT Application Software (P990001/S123)Medtronic, Inc.2025-03-20
Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators with Cardiac Resynchicnization (P010031/S884)Medtronic Cardiac Rhythm Disease Management2025-03-20
MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF (P980050/S145)Medtronic, Inc.2025-03-20
Versatrax Model 7000 Universal A-V Pulse Generator (P820003/S144)Medtronic Cardiac Rhythm Disease Management2025-03-20
Medtronic Insync Biventrical Pacing System (P010015/S558)Medtronic, Inc.2025-03-20
IntellaNav ST Ablation Catheter (P920047/S135)Boston Scientific Corp2025-03-20
Medtronic(R) Transvene Lead System (P920015/S297)Medtronic, Inc.2025-03-20
Medtronic(R) Legend Plus(TM) Pulse Generator (P930022/S020)Medtronic, Inc.2025-03-20
Medtronic Kappa 700/600 Series Pulse Generators and Model 9953 Software (P980035/S807)Medtronic, Inc.2025-03-20
Medtronic (R) CapSure (R) EPI Pacing Lead (P950024/S114)Medtronic, Inc.2025-03-20
IntellaNav MiFi XP Ablation Catheter (P020025/S144)Boston Scientific2025-03-20
Attain Starfix Model 4195 Lead (P060039/S118)Medtronic, Inc.2025-03-20
RADIESSE Injectable Implant (P050037/S142)Merz North America, Inc.2025-03-20
Medtronic Micra Transcatheter Pacemaker System (P150033/S201)Medtronic, Inc.2025-03-20
DePuy Ceramax Ceramic Total Hip System (P070026/S114)DePuy Orthopaedics, Inc.2025-03-19
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (P000058/S094)Medtronic Sofamor Danek USA, Inc.2025-03-19
INFUSE® Bone Graft (P000054/S074)Medtronic Sofamor Danek USA, Inc.2025-03-19
INFUSE® Bone Graft (P050053/S065)Medtronic, Inc.2025-03-19
LCS® Total Knee System (P830055/S340)Depuy, Inc.2025-03-19
ColoHealth (P130001/S009)New Day Diagnostics, LLC2025-03-19
ARCTIC FRONT CRYOCATHETER SYSTEM (P100010/S151)Medtronic Cryocath, LP2025-03-18
AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S206)Boston Scientific Corp2025-03-18
OPTIMIZER Smart System (P180036/S037)Impulse Dynamics (Usa), Inc.2025-03-18
Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S559)Medtronic, Inc.2025-03-18
Cobalt MRI ICD; Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI DF-1 ICD; Evera MRI ICD; (P980016/S919)Medtronic Cardiac Rhythm Disease Management2025-03-18
Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Vers (P980035/S808)Medtronic, Inc.2025-03-18
Micra AV TPS; Micra TPS; Micra VR TPS (P150033/S202)Medtronic, Inc.2025-03-18
HeartMate 3™ Left Ventricular Assist System (P160054/S099)ABBOTT MEDICAL2025-03-18
BioGlue® Surgical Adhesive (P010003/S042)Cryolife, Inc.2025-03-18
Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava CRT-D; Brava Quad CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; (P010031/S885)Medtronic Cardiac Rhythm Disease Management2025-03-18
Aurora EV-ICD (P220012/S045)Medtronic, Inc.2025-03-18
WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System (P030017/S381)Boston Scientific Corp2025-03-17
BIOFINITY (COMFILCON A) (P080011/S183)CooperVision, Inc.2025-03-17
Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophillic) Contact Lens (P980006/S037)Bausch & Lomb, Inc.2025-03-17
Deep Brain Stimulation (DBS) (P150031/S082)Boston Scientific Corp2025-03-17
H55 HYDROPHILIC CONTACT LENS (P890023/S054)The Cooper Companies2025-03-17
Spinal Cord Stimulation (SCS) (P030017/S382)Boston Scientific Corp2025-03-17
LIFEPAK® 35 monitor/defibrillator (P160026/S053)Physio-Control, Inc.2025-03-17
SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S440)Medtronic, Inc.2025-03-14
InterStim® Therapy System, Verify® Evaluation System (P970004/S420)Medtronic Neuromodulation2025-03-14
TREO Abdominal Stent-Graft System (P190015/S023)Bolton Medical, Inc.2025-03-14
GORE CARDIOFORM Septal Occluder (P050006/S115)W. L. Gore & Associates, Inc.2025-03-14
COLOGUARD (P130017/S062)Exact Sciences Corporation2025-03-14
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Every clearance here is in the API, with alerts when new ones post.