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calendar

2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma

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type: device pma×clear all
type
  • approval18,987
  • device 510k5,000
  • phase readout4,876
  • grant4,728
  • 8k filing2,415
  • device pma2,000
  • device recall2,000
  • recall1,126
  • device adverse event1,000
  • earnings295
  • therapy area

    no tagged catalysts yet

    Week of Dec 1, 2025

    29
    ›Dec 1, 2025device pma236d agoAbbott — CentriMag™ Circulatory Support System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 2, 2025device pma235d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma234d 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 pma233d 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 pma233d 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 pma233d 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 pma233d 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 pma233d 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 pma233d 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 pma232d 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 pma232d 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 pma232d 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 pma232d 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 pma232d 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 pma232d 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

    21
    ›Dec 8, 2025device pma229d 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 24 of 40
    next →
    229d 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 pma229d 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 pma229d agoFlow Neuroscience AB — Flow FL-100 (PMA)

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

    full page →fda device pma ↗
    ›Dec 8, 2025device pma229d 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 pma229d 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 pma228d 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 pma228d 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 pma228d 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 pma228d 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 pma228d 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 pma228d 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 pma228d 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 pma228d 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 pma228d 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 pma228d agoProverum, Ltd. — ProVee System for BPH (PMA)

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

    full page →fda device pma ↗
    ›Dec 9, 2025device pma228d 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 pma227d 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 pma227d 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 pma227d 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 pma227d agoCompanion Spine France Sas — DIAM­™ Spinal Stabilization System (PMA)

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

    full page →fda device pma ↗
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $BSX44.25+1.54%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $MDT83.21+1.46%
    $BSX44.25+1.54%
    $STAA23.38-3.35%