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Medtronic, Inc.

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

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RecordFirmDate
SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (P860004/S446)Medtronic, Inc.2025-07-17
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S445)Medtronic, Inc.2025-07-17
CapSureFix Novus Lead 5076; Vitatron Crystalline ActFix Lead ICF09B (P930039/S273)Medtronic, Inc.2025-07-16
print Quattro Lead 6935M; Sprint Quattro Lead 6947M; Sprint Quattro Lead 6947; Sprint Quattro Lead 6935 (P920015/S301)Medtronic, Inc.2025-07-16
CapSure VDD-2 Lead 5038, 5038L, 5038S; Vitatron Brilliant S+ VDD Lead IMW14Q, IMW15Q, IMW16Q; Vitatron Brilliant S+VDD L (P890003/S480)Medtronic, Inc.2025-07-16
CapSure Epicardial Pacing Lead 4965; CapSure Epicardial Pacing Lead 4968 (P950024/S115)Medtronic, Inc.2025-07-16
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S512)Medtronic, Inc.2025-07-16
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S506)Medtronic, Inc.2025-07-15
SmartSync™ Pacing System Analyzer (P890003/S476)Medtronic, Inc.2025-07-15
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (P140010/S096)Medtronic, Inc.2025-07-15
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (P140010/S094)Medtronic, Inc.2025-07-10
Epsila EV Extravascular Lead EV2401 (P220012/S053)Medtronic, Inc.2025-07-09
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax (P140010/S095)Medtronic, Inc.2025-07-09
Sprint Quattro Lead 6935M, Sprint Quattro Lead 6946M, Sprint Quattro Lead 6947, Sprint Quattro Lead 6947M, Sprint Quattr (P920015/S300)Medtronic, Inc.2025-07-09
Micra AV TPS MC1lAVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (P150033/S211)Medtronic, Inc.2025-07-09
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S093)Medtronic, Inc.2025-07-09
Sphere-9 Catheter and Affera Ablation System (P240013/S011)Medtronic, Inc.2025-07-07
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S509)Medtronic, Inc.2025-07-03
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S210)Medtronic, Inc.2025-07-02
MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S816)Medtronic, Inc.2025-07-02
Aurora EV-ICD System (P220012/S052)Medtronic, Inc.2025-07-02
MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S566)Medtronic, Inc.2025-07-02
CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead (P930039/S272)Medtronic, Inc.2025-06-27
PulseSelect™ Pulsed Field Ablation (PFA) system (P230017/S007)Medtronic, Inc.2025-06-27
Sphere-9 Catheter and Affera Ablation System (P240013/S009)Medtronic, Inc.2025-06-26
Avalus Bioprosthesis, Model 400 (P170006/S037)Medtronic, Inc.2025-06-26
Avalus Bioprosthesis, Model 400 (P170006/S036)Medtronic, Inc.2025-06-26
Freestyle Bioprosthesis, Models 995, 995CS, 995MS (P970031/S075)Medtronic, Inc.2025-06-26
Mosaic Bioprosthesis, Models 305, 310 (P990064/S092)Medtronic, Inc.2025-06-26
Hancock II Bioprosthesis, Models T505, T510 (P980043/S083)Medtronic, Inc.2025-06-26
CapSureFix Novus Lead (P930039/S271)Medtronic, Inc.2025-06-20
2292 Analyzer Cable (P890003/S478)Medtronic, Inc.2025-06-20
Adapta, Versa, Sensia IPG (P980035/S814)Medtronic, Inc.2025-06-20
Micra AV TPS MC1AVR1, Micra AV2 TPS MC2AVR1, Micra TPS MC1VR01, Micra VR2 TPS MC2VR01 (P150033/S209)Medtronic, Inc.2025-06-18
MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S815)Medtronic, Inc.2025-06-18
SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S479)Medtronic, Inc.2025-06-18
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S444)Medtronic, Inc.2025-06-18
Aurora EV-ICD System (P220012/S051)Medtronic, Inc.2025-06-18
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S507)Medtronic, Inc.2025-06-18
Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02; Ser (P010015/S565)Medtronic, Inc.2025-06-18
CareLink SmartSync Device Manager Base, 24970A (P890003/S477)Medtronic, Inc.2025-06-17
Astra S DR MRI IPG, X3DR01; Astra S SR MRI IPG, X3SR01; Astra XT DR MRI IPG, X1DR01; Astra XT SR MRI IPG, X1SR01; Azure (P980035/S813)Medtronic, Inc.2025-06-17
Percepta Bipolar CRT- P, WlTR0l; Percepta Quadripolar CRT-P, W4TR01; Serena Bipolar CRT-P, W1TR02; Serena Quadripolar CR (P010015/S564)Medtronic, Inc.2025-06-17
Aurora EV ICD DVEA3E4 (P220012/S049)Medtronic, Inc.2025-06-13
PulseSelect™ Pulsed Field Ablation (PFA) system (P230017/S006)Medtronic, Inc.2025-06-13
Adapta, Versa, Sensia IPG ADDRS1, VEDR01; Adapta, Versa, Sensia IPG ADDR03, ADDRL1, ADSR03, SESR01; Adapta, Versa, Sensi (P980035/S812)Medtronic, Inc.2025-06-13
Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser (P010015/S563)Medtronic, Inc.2025-06-13
Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (P150033/S207)Medtronic, Inc.2025-06-13
Harmony Transcatheter Pulmonary Valve System (P200046/S042)Medtronic, Inc.2025-06-12
Activa™ and Percept™ Deep Brain Stimulation Therapy System (P960009/S503)Medtronic, Inc.2025-06-10
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S268)Medtronic, Inc.2025-06-05
CapSureFix MRI Lead (P090013/S335)Medtronic, Inc.2025-06-05
OmniaSecure™ MRI SureScan™ Lead Model 3930M (P240036/S001)Medtronic, Inc.2025-06-04
Epsila EV Extravascular Lead (EV2401) (P220012/S050)Medtronic, Inc.2025-05-30
Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser (P010015/S562)Medtronic, Inc.2025-05-30
Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR (P980035/S811)Medtronic, Inc.2025-05-30
Sphere-9 Catheter and Affera Ablation System (P240013/S007)Medtronic, Inc.2025-05-30
HV Splitter/Adaptor kit (5019); Sprint Quattro Lead (6947M); Sprint Quattro Lead (6946M); Sprint Quattro Lead (6935M) (P920015/S299)Medtronic, Inc.2025-05-30
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (P140010/S092)Medtronic, Inc.2025-05-29
Sphere-9 Ablation and Mapping Catheter - AFR-00001 (P240013/S006)Medtronic, Inc.2025-05-22
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense TM (P960009/S505)Medtronic, Inc.2025-05-21
SynchroMed® Infusion System, Ascenda ® Intrathecal Catheters (P860004/S442)Medtronic, Inc.2025-05-21
Epsila EV Transverse Tunneling Tool (P220012/S044)Medtronic, Inc.2025-05-15
MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD (P080006/S191)Medtronic, Inc.2025-05-14
Harmony™ Transcatheter Pulmonic Valve System (P200046/S041)Medtronic, Inc.2025-05-13
CapSureFix MRI Lead (P090013/S333)Medtronic, Inc.2025-05-06
CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, Vitatron Crystalline Active Fixation Lead (P930039/S263)Medtronic, Inc.2025-05-06
Micra Transcatheter Pacing System: MC1AVR1; MC2AVR1; MC1VR01; MC2VR01 (P150033/S206)Medtronic, Inc.2025-05-01
Aurora EV ICD DVEA3E4 (P220012/S048)Medtronic, Inc.2025-04-25
Micra AV TPS MC1AVR1, MC2AVR1 Micra TPS MC1VR01 Micra VR TPS MC2VR01 (P150033/S205)Medtronic, Inc.2025-04-25
Consulta CRT-P C4TR01 Percepta Bipolar CRT-P W1TR01 Percepta Quadripolar CRT-P W4TR01 Serena Bipolar CRTP W1TR02 Serena (P010015/S561)Medtronic, Inc.2025-04-25
Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR (P980035/S810)Medtronic, Inc.2025-04-25
OmniaSecure™ MRI SureScan™ Lead Model 3930M (P240036)Medtronic, Inc.2025-04-22
Hancock II Bioprosthesis (P980043/S082)Medtronic, Inc.2025-04-16
Micra AV TPS MC1AVR1, MC2AVR1; Micra TPS MC1VR01; Micra VR TPS MC2VR01 (P150033/S204)Medtronic, Inc.2025-04-16
Freestyle Bioprosthesis (P970031/S074)Medtronic, Inc.2025-04-16
Mosaic Bioprosthesis (P990064/S091)Medtronic, Inc.2025-04-16
Harmony TPV System (P200046/S040)Medtronic, Inc.2025-04-14
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S504)Medtronic, Inc.2025-04-11
Symplicity G3 Renal Denervation RF Generator; Symplicity Spyral Multi-Electrode Renal Denervation Catheter (P220026/S012)Medtronic, Inc.2025-04-10
Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtronic Evolut FX Transcatheter Aortic Valve; Medtronic Evolut FX+ T (P130021/S176)Medtronic, Inc.2025-04-08
Harmony Transcatheter Pulmonic Valve (TPV) System (P200046/S039)Medtronic, Inc.2025-04-07
CoreValve EnVeo Pro Delivery Catheter System; CoreValve EnVeo Pro Loading System; Evolut PRO+ Delivery Catheter System; (P130021/S175)Medtronic, Inc.2025-04-07
Symplicity Spyral Renal Denervation Catheter (P220026/S011)Medtronic, Inc.2025-04-07
Harmony™ Delivery Catheter System (P200046/S038)Medtronic, Inc.2025-04-07
Aurora EV-ICD (P220012/S047)Medtronic, Inc.2025-04-03
Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (P010015/S560)Medtronic, Inc.2025-04-03
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/S809)Medtronic, Inc.2025-04-03
Aurora EV ICD DVEA3E4 (P220012/S046)Medtronic, Inc.2025-04-02
Sprint Quattro Lead (P920015/S298)Medtronic, Inc.2025-04-01
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S203)Medtronic, Inc.2025-03-27
MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) (P140017/S030)Medtronic, Inc.2025-03-27
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated (P140010/S087)Medtronic, Inc.2025-03-26
Symplicity Spyral Multi-Electrode Renal Denervation Catheter (P220026/S013)Medtronic, Inc.2025-03-21
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
Revo MRI Surescan IPG and Pacing System (P090013/S336)Medtronic, Inc.2025-03-20
Synergyst II Pulse Generator Models 7070 & 7071 (P890003/S475)Medtronic, Inc.2025-03-20
Model 5071 Lead (P120017/S038)Medtronic, Inc.2025-03-20
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