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calendar

849 catalysts · 3,312 8k filing · 2,283 grant · 1,778 approval · 1,169 device 510k · 1,000 device adverse event · 849 device pma

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2026-08-10: 0 catalysts2026-08-11: 0 catalysts2026-08-12: 0 catalysts2026-08-13: 0 catalysts2026-08-14: 28 catalysts2026-08-15: 0 catalysts2026-08-16: 0 catalysts2026-08-17: 1 catalyst2026-08-18: 2 catalysts2026-08-19: 3 catalysts2026-08-20: 0 catalysts2026-08-21: 0 catalysts2026-08-22: 0 catalysts2026-08-23: 0 catalysts2026-08-24: 0 catalysts2026-08-25: 0 catalysts2026-08-26: 1 catalyst2026-08-27: 1 catalyst2026-08-28: 0 catalysts2026-08-29: 0 catalysts2026-08-30: 0 catalysts2026-08-31: 0 catalysts2026-09-01: 1 catalyst2026-09-02: 0 catalysts2026-09-03: 1 catalyst2026-09-04: 0 catalysts2026-09-05: 0 catalysts2026-09-06: 0 catalysts2026-09-07: 0 catalysts2026-09-08: 0 catalysts2026-09-09: 0 catalysts2026-09-10: 0 catalysts2026-09-11: 0 catalysts2026-09-12: 0 catalysts2026-09-13: 0 catalysts2026-09-14: 0 catalysts2026-09-15: 0 catalysts2026-09-16: 0 catalysts2026-09-17: 0 catalysts2026-09-18: 0 catalysts2026-09-19: 0 catalysts2026-09-20: 0 catalysts2026-09-21: 0 catalysts2026-09-22: 0 catalysts2026-09-23: 2 catalysts2026-09-24: 0 catalysts2026-09-25: 0 catalysts2026-09-26: 0 catalysts2026-09-27: 0 catalysts2026-09-28: 0 catalysts2026-09-29: 0 catalysts2026-09-30: 0 catalysts2026-10-01: 0 catalysts2026-10-02: 0 catalysts2026-10-03: 0 catalysts2026-10-04: 0 catalysts2026-10-05: 0 catalysts2026-10-06: 0 catalysts2026-10-07: 0 catalysts2026-10-08: 2 catalysts2026-10-09: 0 catalysts2026-10-10: 0 catalysts2026-10-11: 0 catalysts2026-10-12: 0 catalysts2026-10-13: 1 catalyst2026-10-14: 1 catalyst2026-10-15: 0 catalysts2026-10-16: 0 catalysts2026-10-17: 0 catalysts2026-10-18: 0 catalysts2026-10-19: 1 catalyst2026-10-20: 2 catalysts2026-10-21: 2 catalysts2026-10-22: 2 catalysts2026-10-23: 1 catalyst2026-10-24: 0 catalysts2026-10-25: 0 catalysts2026-10-26: 1 catalyst2026-10-27: 8 catalysts2026-10-28: 12 catalysts2026-10-29: 21 catalysts2026-10-30: 4 catalysts2026-10-31: 0 catalysts2026-11-01: 0 catalysts2026-11-02: 9 catalysts2026-11-03: 18 catalysts2026-11-04: 22 catalysts2026-11-05: 37 catalysts2026-11-06: 2 catalysts2026-11-07: 0 catalysts2026-11-08: 0 catalysts
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type: device pma×from 2025-12-02×clear all
type
  • 8k filing3,312
  • grant2,283
  • approval1,778
  • device 510k1,169
  • device adverse event1,000
  • device pma849
device recall
655
  • earnings584
  • recall282
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 1, 2025

    28
    ›Dec 2, 2025device pma256d agoMedtronic, Inc. — Micra A V2 TPS (MC2AVR1); Micra VR2 TPS (MC2VR01) (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoNeuros Medical, Inc. — Altius® Direct Electrical Nerve Stimulation System (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: SAZ. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic, Inc. — CareLink SmartSync Device Manager Base 24970A (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DVPB3D1, DDPB3D1, DDPB3D4, DVPB3D4 LWS, NVZ Cobalt XT MRI ICD DVPA2D1, DVPA2D4, DDPA2D1, DDPA2D4 LWS, NVZ (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD ; Crome MRI ICD (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic, Inc. — Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic, Inc. — Aurora EV ICD DVEA3E4 (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoSiemens Healthcare Diagnostics, Inc. — Atellica IM Total PSA II (tPSAII) (PMA)

    Product code: MTF. Advisory committee: IM. Decision: APPR

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4, Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ NIK Brava CRT-D DTBC1D1 KRG, NIK Brava CRT-D D (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic, Inc. — Aurora EV ICD (DVEA3E4) (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 3, 2025device pma255d agoMedtronic, Inc. — Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (PMA supplement)Medtronic plc

    Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 4, 2025device pma254d agoBausch and Lomb, Inc., — Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30

    full page →fda device pma ↗
    ›Dec 4, 2025device pma254d agoPhysio-Control, Inc. — LIFEPAK® 35 Defibrillator/monitor (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 4, 2025device pma254d agoLenstec, Inc. — Softec HD; Softec I; Softec HDO; Softec HDM (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: HQL. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Dec 4, 2025device pma254d agoLenstec, Inc. — ClearView 3 (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: MFK. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Dec 4, 2025device pma254d agoCordis US Corporation — S.M.A.R.T.® CONTROL® Nitinol Stent System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIO. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 4, 2025device pma254d agoCordis US Corporation — S.M.A.R.T. and S.M.A.R.T.® CONTROL® Vascular Stent Systems (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 5, 2025device pma253d agoBoston Scientific Corp — Intellagen™ Irrigation Tubing Set (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: Normal 180 Day Track. Product code: OAD. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 5, 2025device pma253d agoCooperVision, Inc. — Sofmed® breathables™ XW NEXT (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: LPM. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Dec 5, 2025device pma253d agoW. L. Gore and Associates, Inc. — GORE® EXCLUDER® Conformable AAA Endoprosthesis (PMA supplement)

    Supplement type: Real-Time Process. Product code: MIH. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 5, 2025device pma253d agoMedtronic Minimed, Inc. — Simplera Sync Sensor (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Dec 5, 2025device pma253d agoMedtronic Minimed — Simplera System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Dec 5, 2025device pma253d agoMedtronic Minimed, Inc. — MiniMed 780G System (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗

    Week of Dec 8, 2025

    22
    ›Dec 8, 2025device pma250d agoMedtronic Minimed, Inc. — MiniMed 780G System (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Dec 8, 2025device pma
    ← prev
    page 1 of 17
    next →
    250d ago
    Medtronic, Inc. — Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (PMA supplement)Medtronic plc

    Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Dec 8, 2025device pma250d agoMedtronic Minimed — Simplera System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MDS. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Dec 8, 2025device pma250d agoFlow Neuroscience AB — Flow FL-100 (PMA)

    Product code: JXK. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Dec 8, 2025device pma250d agoEv3 Neurovascular — Onyx Liquid Embolic System (LES) (PMA supplement)

    Supplement type: Panel Track. Product code: SGU. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Dec 8, 2025device pma250d agoMedtronic Minimed, Inc. — Simplera Sync Sensor (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    ›Dec 9, 2025device pma249d agoAbbott Vascular, Inc. — XACT® Carotid Stent System (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: NIM. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 9, 2025device pma249d agoZoll Manufacturing Corporation — LifeVest® Wearable Defibrillator (PMA supplement)

    Supplement type: Real-Time Process. Product code: MVK. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 9, 2025device pma249d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Dec 9, 2025device pma249d agoAbbott Vascular, Inc. — Perclose ProGlide® Suture-Mediated Closure System; Prostar® XL Percutaneous Vascular Surgical System (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: MGB. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 9, 2025device pma249d agoZOLL Medical Corporation — ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci (PMA supplement)

    Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 9, 2025device pma249d agoDePuy Orthopaedics, Inc. — Ceramax Ceramic Hip System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30

    full page →fda device pma ↗
    ›Dec 9, 2025device pma249d agoAbbott Vascular Devices — StarClose SE® Vascular Surgical System (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: MGB. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 9, 2025device pma249d agoABBOTT MEDICAL — Tendril STS Leads; Ultipace Leads (PMA supplement)

    Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 9, 2025device pma249d agoABBOTT MEDICAL — Durata Leads; Optisure Leads (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 9, 2025device pma249d agoProverum, Ltd. — ProVee System for BPH (PMA)

    Product code: MER. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Dec 9, 2025device pma249d agoAbbott Vascular (Idef Technologies Inc) — Supera™ Peripheral Stent System (PMA supplement)

    Supplement type: Normal 180 Day Track No User Fee. Product code: NIP. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 10, 2025device pma248d agoBoston Scientific Corp — Vercise Genus™ Deep Brain Stimulation (DBS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

    Supplement type: Real-Time Process. Product code: NHL. Advisory committee: NE. Decision: APPR

    full page →fda device pma ↗
    ›Dec 10, 2025device pma248d agoBiotronik, Inc. — Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53; Siello S 45; Sie (PMA supplement)

    Supplement type: 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: OK30

    full page →fda device pma ↗
    ›Dec 10, 2025device pma248d agoSTAAR Surgical Company — Visian® Toric Implantable Collamer® Lens (TICL) (PMA supplement)STAAR SURGICAL CO

    Supplement type: Normal 180 Day Track No User Fee. Product code: QCB. Advisory committee: OP. Decision: APPR

    full page →fda device pma ↗
    ›Dec 10, 2025device pma248d agoCompanion Spine France Sas — DIAM­™ Spinal Stabilization System (PMA)

    Product code: NQO. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Dec 10, 2025device pma248d agoMedtronic Minimed, Inc. — MiniMed 670G system MiniMed 770G system MiniMed 780G system (PMA supplement)Medtronic USA Inc

    Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

    full page →fda device pma ↗
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $MDT90.58-0.20%
    $BSX52.44+1.44%
    $BSX52.44+1.44%
    $MDT90.58-0.20%
    $STAA25.33-0.31%