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Registry

363 FDA decisions, each verified against the agency record

20 510(k) clearances and 343 PMA decisions for electrophysiology devices, newest first. The identifier links to the FDA record.

DateApplicantDeviceIdentifierKind
2026-09-04Peerbridge Health, Inc.Peerbridge COR MDx (Cor MDx)K253529510(k)
2026-09-04Farapulse, Inc.FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FARASTAR™ Recording System Modul truncated in FDA recordP230030/S024PMA supplement
2026-09-03Irvine Biomedical, Inc.Therapy™ (including Bi-Directional and 4mm Thermistor) Ablation CatheterP040014/S052PMA supplement
2026-09-03Irvine Biomedical,Inc.(Ibi)Therapy™ Dual-8™ Ablation CatheterP040042/S060PMA supplement
2026-09-02Biosense Webster, Inc.THERMOCOOL SMARTTOUCH® SF CatheterP030031/S142PMA supplement
2026-08-28Medtronic, Inc.LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)K262735510(k)
2026-08-27Stereotaxis, Inc.GenesisX RMNK262744510(k)
2026-08-27ABBOTT MEDICALAveir VR Leadless SystemP150035/S041PMA supplement
2026-08-27Biotronik, Inc.Solia CSP SP950037/S297PMA supplement
2026-08-25Boston Scientific CorpTachy Pulse GeneratorsP010012/S612PMA supplement
2026-08-25Farapulse, Inc.FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, truncated in FDA recordP230030/S016PMA supplement
2026-08-25Boston ScientificTachy Pulse GeneratorsP960040/S515PMA supplement
2026-08-20Kardium, Inc.Globe® Catheter Laminated RibsP240044/S006PMA supplement
2026-08-19Medtronic, Inc.MEDTRONIC(R) TRANSVENE LEAD SYSTEMP920015/S307PMA supplement
2026-08-17Biosense Webster, Inc.TX eco CableP210027/S017PMA supplement
2026-08-14Schiller AGmedilogFDK253562510(k)
2026-08-12ABBOTT MEDICALAvant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T, CDHFA600Q, truncated in FDA recordP030054/S446PMA supplement
2026-08-12ABBOTT MEDICALAvant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA600T, truncated in FDA recordP910023/S487PMA supplement
2026-08-11ABBOTT MEDICALVolt™ PFA Catheter, Sensor Enabled™P250022/S008PMA supplement
2026-08-07Irvine Biomedical, Inc.Ampere GeneratorP040014/S051PMA supplement
2026-08-07Irvine Biomedical,Inc.(Ibi)Ampere GeneratorP040042/S059PMA supplement
2026-08-07Irvine Biomedical, Inc.Ampere GeneratorP060019/S059PMA supplement
2026-08-07ABBOTT MEDICALAmpere GeneratorP110016/S095PMA supplement
2026-08-07St Jude MedicalTactiSys Quartz Equipment; Ampere GeneratorP130026/S102PMA supplement
2026-08-07ABBOTT MEDICALTactiSys Quartz Equipment; Ampere GeneratorP220013/S033PMA supplement
2026-08-07St Jude MedicalAmpere GeneratorP960016/S094PMA supplement
2026-08-06Medtronic Cryocath, LPStop AF FirstP100010/S152PMA supplement
2026-08-06Farapulse, Inc.FARAPULSE™ Pulsed Field Ablation SystemP230030/S018PMA supplement
2026-08-06Medtronic, Inc.Sphere-9 Catheter AFR-00001P240013/S030PMA supplement
2026-08-05Medtronic Cardiac Rhythm Disease ManagementSelectSecure Lead 3830P030036/S161PMA supplement
2026-08-04Medtronic, Inc.Sphere-9 Catheter and Affera Ablation SystemP240013/S029PMA supplement
2026-07-31Medtronic, Inc.Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T truncated in FDA recordP010015/S588PMA supplement
2026-07-31Medtronic, Inc.Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar truncated in FDA recordP010015/S589PMA supplement
2026-07-31Medtronic Cardiac Rhythm Disease ManagementAmplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4);Brava Quad truncated in FDA recordP010031/S928PMA supplement
2026-07-31Medtronic Cardiac Rhythm Disease ManagementCobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome MR truncated in FDA recordP010031/S929PMA supplement
2026-07-31Medtronic Cardiac Rhythm Disease ManagementAmplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4) Brava Quad truncated in FDA recordP010031/S930PMA supplement
2026-07-31Medtronic, Inc.Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)P150033/S228PMA supplement
2026-07-31Medtronic, Inc.Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01)P150033/S229PMA supplement
2026-07-31Medtronic, Inc.Aurora EV ICD (DVEA3E4)P220012/S074PMA supplement
2026-07-31Medtronic, Inc.Aurora EV-ICD (DVEA3E4)P220012/S075PMA supplement
2026-07-31Stereotaxis, Inc.MAGiC Ablation CatheterP240014/S001PMA supplement
2026-07-31Medtronic Cardiac Rhythm Disease ManagementCobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I truncated in FDA recordP980016/S961PMA supplement
2026-07-31Medtronic Cardiac Rhythm Disease ManagementCobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I truncated in FDA recordP980016/S962PMA supplement
2026-07-31Medtronic Cardiac Rhythm Disease ManagementEvera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S DR truncated in FDA recordP980016/S963PMA supplement
2026-07-30Swift Sync, Inc.Sync AV II Temporary Pacing CatheterK252042510(k)
2026-07-30Zoll Manufacturing CorporationLifeVest® Wearable DefibrillatorP010030/S202PMA supplement
2026-07-24Boston Scientific CorporationFARADRIVE™ Steerable Sheath (M004PF21M402)K262165510(k)
2026-07-23Boston Scientific CorpESSENTIO™ SR SL (L100); ESSENTIO™ DR SL (L101); ESSENTIO™ DR EL (L121); PROPONENT™ SR SL (L200); PROPONENT™ DR SL (L201) truncated in FDA recordN970003/S309PMA supplement
2026-07-23Boston Scientific CorpMOMENTUM™ CRT-D IS1 DF4 IS1 (G124, G125); MOMENTUM™ CRT-D IS1 DF1 LV1 (G126); MOMENTUM™ X4 CRT-D IS1 DF1 IS4 (G128, G138 truncated in FDA recordP010012/S613PMA supplement
2026-07-23Guidant Corp.VALITUDE™ CRT-P IS1 EL (U125); VALITUDE™ CRT-P IS4 EL (U128); VISIONIST™ CRT-P IS1 EL (U225); VISIONIST™ CRT-P LV1 EL (U truncated in FDA recordP030005/S255PMA supplement

Source: openFDA device/510k and device/pma, verified rows only, as the FDA names each applicant and device; last verified 20 September 2026.