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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/S455)Medtronic, Inc.2025-12-22
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527)Medtronic, Inc.2025-12-22
Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574)Medtronic, Inc.2025-12-19
SynchroMed™ Infusion Systems (P860004/S453)Medtronic, Inc.2025-12-19
Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526)Medtronic, Inc.2025-12-18
Activa™ Deep Brain Stimulation Therapy System (P960009/S514)Medtronic, Inc.2025-12-17
Aurora EV-ICD System (P220012/S061)Medtronic, Inc.2025-12-15
Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (P960009/S524)Medtronic, Inc.2025-12-08
Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01 (P150033/S219)Medtronic, Inc.2025-12-03
Aurora EV ICD DVEA3E4 (P220012/S060)Medtronic, Inc.2025-12-03
CareLink SmartSync Device Manager Base 24970A (P890003/S483)Medtronic, Inc.2025-12-03
Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S575)Medtronic, Inc.2025-12-03
Aurora EV ICD (DVEA3E4) (P220012/S062)Medtronic, Inc.2025-12-03
Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen (P980035/S827)Medtronic, Inc.2025-12-03
Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0 (P980035/S826)Medtronic, Inc.2025-12-03
Micra A V2 TPS (MC2AVR1); Micra VR2 TPS (MC2VR01) (P150033/S218)Medtronic, Inc.2025-12-02
Activa™ Deep Brain Stimulation Therapy System, Percept PC BrainSense™ (P960009/S525)Medtronic, Inc.2025-11-26
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S454)Medtronic, Inc.2025-11-26
Micra Transcatheter Pacing Systems (P150033/S217)Medtronic, Inc.2025-11-25
Medtronic DBS Therapy for Dystonia (P960009/S482)Medtronic, Inc.2025-11-22
Sphere-9 TM Mapping and Ablation Catheter (P240013/S018)Medtronic, Inc.2025-11-20
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S521)Medtronic, Inc.2025-11-13
SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (P860004/S451)Medtronic, Inc.2025-11-13
Mosaic Bioprosthesis (P990064/S093)Medtronic, Inc.2025-11-10
Freestyle Bioprosthesis (P970031/S076)Medtronic, Inc.2025-11-10
Avalus Bioprosthesis, Avalus Ultra Bioprosthesis (P170006/S038)Medtronic, Inc.2025-11-10
Hancock II Bioprosthesis (P980043/S084)Medtronic, Inc.2025-11-10
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S508)Medtronic, Inc.2025-11-04
OmniaSecure™ MRI SureScan™ Lead Model 3930M (P240036/S003)Medtronic, Inc.2025-10-30
SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S481)Medtronic, Inc.2025-10-30
Avalus Bioprosthesis (P170006/S041)Medtronic, Inc.2025-10-30
OmniaSecure™ MRI SureScan™ Lead Model 3930M (P240036/S002)Medtronic, Inc.2025-10-29
Aurora EV ICD (DVEA3E4) (P220012/S059)Medtronic, Inc.2025-10-28
Harmony™ Transcatheter Pulmonary Valve (P200046/S044)Medtronic, Inc.2025-10-23
Melody™ Transcatheter Pulmonary Valve (P140017/S032)Medtronic, Inc.2025-10-23
Mosaic Bioprosthesis, Models 305, 310 (P990064/S095)Medtronic, Inc.2025-10-23
Hancock II Bioprosthesis, Models T505, T510 (P980043/S085)Medtronic, Inc.2025-10-23
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S523)Medtronic, Inc.2025-10-23
Avalus Bioprosthesis, Model 400 (P170006/S039)Medtronic, Inc.2025-10-23
Freestyle Bioprosthesis, Models 995, 995CS, 995MS (P970031/S077)Medtronic, Inc.2025-10-23
Medtronic Evolut™ PRO+ Delivery Catheter System (P130021/S178)Medtronic, Inc.2025-10-22
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S522)Medtronic, Inc.2025-10-16
SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (P860004/S452)Medtronic, Inc.2025-10-16
DiamondTemp Ablation System (P200028/S026)Medtronic, Inc.2025-10-10
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/S824)Medtronic, Inc.2025-10-08
Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S573)Medtronic, Inc.2025-10-08
PulseSelect™ Pulsed Field Ablation (PFA) system (P230017/S008)Medtronic, Inc.2025-10-08
Sphere-9 Catheter and Affera Ablation System (P240013/S017)Medtronic, Inc.2025-10-07
Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S572)Medtronic, Inc.2025-10-03
Aurora EV ICD (DVEA3E4) (P220012/S058)Medtronic, Inc.2025-10-03
Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT SR MRI IPG; Astra (P980035/S823)Medtronic, Inc.2025-10-03
Adapta, Versa, Sensia IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Attesta DR (P980035/S825)Medtronic, Inc.2025-10-02
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/S822)Medtronic, Inc.2025-10-02
Percepta Bipolar CRTP; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P; (P010015/S571)Medtronic, Inc.2025-10-02
Sphere-9 Catheter and Affera Ablation System (P240013/S016)Medtronic, Inc.2025-09-19
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (Drug Delivery Infusion Pump 8667); (Drug Delivery Infusion (P860004/S450)Medtronic, Inc.2025-09-18
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (DBS Neurostimulator Implantable B35200); (DBS Ne (P960009/S518)Medtronic, Inc.2025-09-18
IN.PACT Admiral Paclitaxelcoated PTA Balloon Catheter; IN.PACT 018 Paclitaxel-coated PTA Balloon Catheter (P140010/S100)Medtronic, Inc.2025-09-16
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S519)Medtronic, Inc.2025-09-15
Aurora EV-ICD System (P220012/S054)Medtronic, Inc.2025-09-11
Harmony™ TPV System (P200046/S043)Medtronic, Inc.2025-09-05
Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C (P010015/S570)Medtronic, Inc.2025-09-05
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S449)Medtronic, Inc.2025-09-05
Miera AV TPS (MC1AVR1); Miera A V2 TPS (MC2AVR1); Miera TPS (MC1VR01); Miera VR2 TPS (MC2VR01) (P150033/S216)Medtronic, Inc.2025-09-05
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S517)Medtronic, Inc.2025-09-05
Aurora EV-ICD System (DVEA3E4) (P220012/S057)Medtronic, Inc.2025-09-05
Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az (P980035/S821)Medtronic, Inc.2025-09-05
Sphere-9™ Mapping and Ablation Catheter (P240013/S010)Medtronic, Inc.2025-09-04
Sphere-9 Catheter Mapping and Ablation Catheter (P240013/S015)Medtronic, Inc.2025-08-29
SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S448)Medtronic, Inc.2025-08-29
SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters (P860004/S447)Medtronic, Inc.2025-08-28
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S516)Medtronic, Inc.2025-08-28
Evolut PRO+ System, Evolut FX System, Evolut FX+ System (P130021/S174)Medtronic, Inc.2025-08-27
Melody Transcatheter Pumonary Valve System (P140017/S031)Medtronic, Inc.2025-08-21
Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) (P150033/S215)Medtronic, Inc.2025-08-21
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S208)Medtronic, Inc.2025-08-20
HexaGen™ RF Generator, HexaPulse™ PF Generator, HexaFlow™ Irrigation Pump (P240013/S013)Medtronic, Inc.2025-08-15
Micra Transcatheter Pacing System (Micra AV/VR and Micra AV2/VR2) (P150033/S212)Medtronic, Inc.2025-08-15
Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve; Medtronic Evolut™ PRO+ Transcatheter Aortic Valve; Medtroni (P130021/S177)Medtronic, Inc.2025-08-14
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CR T- (P010015/S568)Medtronic, Inc.2025-08-12
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S099)Medtronic, Inc.2025-08-12
Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (P150033/S214)Medtronic, Inc.2025-08-12
Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, ADSR06; Adapta, Versa, Sensia IPG SED01, SES01; Adapta, Versa, Sensia IPG SED (P980035/S820)Medtronic, Inc.2025-08-12
Aurora EV ICD DVEA3E4 (P220012/S056)Medtronic, Inc.2025-08-12
Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Se (P010015/S569)Medtronic, Inc.2025-08-12
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/S818)Medtronic, Inc.2025-08-12
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S097)Medtronic, Inc.2025-08-12
CareLink SmartSync Device Manager Base (P890003/S482)Medtronic, Inc.2025-08-12
Consulta CRT-P (C4TR01); Syncra CRT-P (C2TR01) (P010015/S567)Medtronic, Inc.2025-08-06
Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01) (P980035/S817)Medtronic, Inc.2025-08-06
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S515)Medtronic, Inc.2025-08-06
AFR-00004 HexaGen RF Generator (RFG) and AFR-00008 HexaPulse PF Generator (PFG) (P240013/S008)Medtronic, Inc.2025-08-01
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S213)Medtronic, Inc.2025-07-29
Aurora EV-ICD System (P220012/S055)Medtronic, Inc.2025-07-29
Adapta, Versa, Sensia IPG (SED01); Adapta, Versa, Sensia IPG (ADSR01, VEDR01); Adapta, Versa, Sensia IPG (ADVDD01); Adap (P980035/S819)Medtronic, Inc.2025-07-29
HexaFlow™ Irrigation Pumo AFR-00004, HexaGen TM RF Generator AFR-00005, HexaPulse TM PF Generator AFR-00008 (P240013/S014)Medtronic, Inc.2025-07-23
Sphere-9 Catheter and Affera Ablation System (HexaFlow™ Irrigation Pump; HexaGen™ RF Generator; HexaPulse™ PF Generator) (P240013/S012)Medtronic, Inc.2025-07-22
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S513)Medtronic, Inc.2025-07-22
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S510)Medtronic, Inc.2025-07-17
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ (P960009/S511)Medtronic, Inc.2025-07-17
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