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Medtronic, Inc.

6,204 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S552)Medtronic, Inc.2024-11-21
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S551)Medtronic, Inc.2024-11-20
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S799)Medtronic, Inc.2024-11-20
Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S194)Medtronic, Inc.2024-11-20
Aurora EV ICD (P220012/S034)Medtronic, Inc.2024-11-20
Carelink SmartSync™ Platform Carelink SmartSync TM Common Application (P890003/S469)Medtronic, Inc.2024-11-15
CareLink SmartSync NuPace Application Software (P890003/S471)Medtronic, Inc.2024-11-14
CareLink SmartSync Percepta Serena Solara App (P010015/S545)Medtronic, Inc.2024-11-14
CareLink SmartSync Micra AV App, CareLink SmartSync Micra Evolution App, CareLink SmartSync Micra VR App (P150033/S191)Medtronic, Inc.2024-11-14
CareLink SmartSync Azure Astra App (P980035/S790)Medtronic, Inc.2024-11-14
Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S193)Medtronic, Inc.2024-11-13
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S265)Medtronic, Inc.2024-11-13
DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Le (P920015/S294)Medtronic, Inc.2024-11-13
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S473)Medtronic, Inc.2024-11-13
Myocardial Pacing Lead (P120017/S037)Medtronic, Inc.2024-11-13
Aurora EV ICD, Epsila EV Extravascular Lead (P220012/S033)Medtronic, Inc.2024-11-13
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S187)Medtronic, Inc.2024-11-13
Transvene CS/SVC Lead (P980050/S144)Medtronic, Inc.2024-11-13
CapSureFix MRI Lead (P090013/S334)Medtronic, Inc.2024-11-13
Attain StarFix Lead (P060039/S117)Medtronic, Inc.2024-11-13
Azure/Astra Implantable Pulse Generator (IPG) (P980035/S788)Medtronic, Inc.2024-11-13
Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Solara (P010015/S549)Medtronic, Inc.2024-11-13
CapSure Epicardial Pacing Lead (P950024/S113)Medtronic, Inc.2024-11-13
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S797)Medtronic, Inc.2024-11-13
INFUSE™ Bone Graft (P050053/S064)Medtronic, Inc.2024-11-06
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG (P980035/S798)Medtronic, Inc.2024-11-05
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S488)Medtronic, Inc.2024-11-05
Consulta CRT-P, Syncra CRT-P (P010015/S550)Medtronic, Inc.2024-11-05
Aurora EV ICD (P220012/S031)Medtronic, Inc.2024-10-30
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S793)Medtronic, Inc.2024-10-25
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S546)Medtronic, Inc.2024-10-25
Sphere-9 Catheter and Affera Ablation System (P240013)Medtronic, Inc.2024-10-24
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S085)Medtronic, Inc.2024-10-21
Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S547)Medtronic, Inc.2024-10-17
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S264)Medtronic, Inc.2024-10-17
Aurora EV ICD, Epsila EV Extravascular Lead (P220012/S032)Medtronic, Inc.2024-10-17
Myocardial Pacing Lead (P120017/S036)Medtronic, Inc.2024-10-17
Micra TPS, Micra VR TPS (P150033/S192)Medtronic, Inc.2024-10-17
Transvene CS/SVC Lead (P980050/S143)Medtronic, Inc.2024-10-17
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S794)Medtronic, Inc.2024-10-17
CapSure Epicardial Pacing Lead (P950024/S112)Medtronic, Inc.2024-10-17
Attain StarFix Lead (P060039/S116)Medtronic, Inc.2024-10-17
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S186)Medtronic, Inc.2024-10-17
DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, Lead Adaptor, Sprint Quattro Lead. Subcutaneous Lead, Transvene C (P920015/S293)Medtronic, Inc.2024-10-17
Percept™ Deep Brain Stimulation Therapy System (P960009/S487)Medtronic, Inc.2024-10-11
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S472)Medtronic, Inc.2024-10-01
IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead (P920015/S292)Medtronic, Inc.2024-10-01
CapSure Epicardial Pacing Lead (P950024/S111)Medtronic, Inc.2024-10-01
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S791)Medtronic, Inc.2024-09-30
Aurora EV-ICD (P220012/S025)Medtronic, Inc.2024-09-27
Evolut FX Delivery Catheter System of the Medtronic Evolut™ FX System (P130021/S168)Medtronic, Inc.2024-09-27
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Relia IPG (P980035/S792)Medtronic, Inc.2024-09-26
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S789)Medtronic, Inc.2024-09-18
Consulta CRT-P,Percepta Bipolar CRT-P,Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara (P010015/S544)Medtronic, Inc.2024-09-18
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S485)Medtronic, Inc.2024-09-16
SynchroMed Infusion System (P860004/S431)Medtronic, Inc.2024-09-16
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S787)Medtronic, Inc.2024-09-12
Aurora EV-ICD (P220012/S030)Medtronic, Inc.2024-09-12
PulseSelect PFA Loop Catheter (P230017/S003)Medtronic, Inc.2024-09-06
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S786)Medtronic, Inc.2024-09-04
Advanced Valve Metal (AVM) capacitor (P220012/S029)Medtronic, Inc.2024-08-28
Symplicity G3 Renal Denervation RF Generator (P220026/S009)Medtronic, Inc.2024-08-21
CapSureFix Novus Lead (P930039/S262)Medtronic, Inc.2024-08-16
Tunneling Tool (P920015/S291)Medtronic, Inc.2024-08-15
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S430)Medtronic, Inc.2024-08-14
Harmony Transcathetrer Pulmonary Valve (P200046/S035)Medtronic, Inc.2024-08-13
Medtronic Core ValvE Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic (P130021/S167)Medtronic, Inc.2024-08-13
DiamondTemp Ablation System (P200028/S024)Medtronic, Inc.2024-08-06
CapSureFix Novus Lead (P930039/S261)Medtronic, Inc.2024-08-01
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S185)Medtronic, Inc.2024-08-01
CapSureFix Novus Lead (P930039/S257)Medtronic, Inc.2024-07-31
CoreValve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Evolut FX Delivery Catheter System (P130021/S165)Medtronic, Inc.2024-07-24
Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S185)Medtronic, Inc.2024-07-22
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S785)Medtronic, Inc.2024-07-21
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S543)Medtronic, Inc.2024-07-21
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S784)Medtronic, Inc.2024-07-17
Percept RC BrainSense (P960009/S484)Medtronic, Inc.2024-07-17
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S542)Medtronic, Inc.2024-07-17
Symplicity G3™ Renal RF Generator (P220026/S005)Medtronic, Inc.2024-07-16
Sprint Quattro Lead (P920015/S290)Medtronic, Inc.2024-07-05
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S474)Medtronic, Inc.2024-07-01
CapSureFix MRI Lead (P090013/S332)Medtronic, Inc.2024-07-01
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S260)Medtronic, Inc.2024-07-01
RF Catheter Cables (P930029/S072)Medtronic, Inc.2024-07-01
Transvene CS/SVC Lead (P920015/S289)Medtronic, Inc.2024-07-01
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead, Vitatron Brilliant S+ VDD Lead (P890003/S468)Medtronic, Inc.2024-07-01
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S481)Medtronic, Inc.2024-06-28
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S429)Medtronic, Inc.2024-06-28
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter IN.PACT 018 Paclitaxel-Co (P140010/S081)Medtronic, Inc.2024-06-27
Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S184)Medtronic, Inc.2024-06-27
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S480)Medtronic, Inc.2024-06-27
HV Splitter/Adaptor kit, Sprint Quattro Lead (P920015/S288)Medtronic, Inc.2024-06-27
Epsila EV Extravascular Lead (P220012/S028)Medtronic, Inc.2024-06-27
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IMG, Astra S DR MRI IG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra X (P980035/S783)Medtronic, Inc.2024-06-27
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S541)Medtronic, Inc.2024-06-27
HV Splitter/Adaptor kit (P920015/S287)Medtronic, Inc.2024-06-21
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S079)Medtronic, Inc.2024-06-21
Core Valve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Valve EnVeo R Delivery Catheter Sys (P130021/S164)Medtronic, Inc.2024-06-20
PulseSelect™ Pulsed Field Ablation (PFA) system (P230017/S001)Medtronic, Inc.2024-06-18
EAZ101 / Epsila EV Sternal Tunneling Tool, EAZ201 / Epsila EV Transverse Tunneling Tool (P220012/S026)Medtronic, Inc.2024-06-05
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