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calendar

833 catalysts · 3,350 8k filing · 2,283 grant · 1,767 approval · 1,155 device 510k · 1,000 device adverse event · 833 device pma

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type: device pma×from 2025-12-04×clear all
type
  • 8k filing3,350
  • grant2,283
  • approval1,767
  • device 510k1,155
  • device adverse event1,000
  • device pma833
device recall
618
  • earnings584
  • recall266
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 1, 2025

    12
    ›Dec 4, 2025device pma255d 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 pma255d 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 pma255d 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 pma255d 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 pma255d 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 pma255d 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 pma254d 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 pma254d 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 pma254d 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 pma254d 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 pma254d 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 pma254d 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

    38
    ›Dec 8, 2025device pma251d 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 →
    251d 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 pma251d 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 pma251d agoFlow Neuroscience AB — Flow FL-100 (PMA)

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

    full page →fda device pma ↗
    ›Dec 8, 2025device pma251d 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 pma251d 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 pma250d 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 pma250d 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 pma250d 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 pma250d 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 pma250d 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 pma250d 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 pma250d 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 pma250d 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 pma250d 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 pma250d agoProverum, Ltd. — ProVee System for BPH (PMA)

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

    full page →fda device pma ↗
    ›Dec 9, 2025device pma250d 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 pma249d 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 pma249d 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 pma249d 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 pma249d 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 pma249d 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 ↗
    ›Dec 10, 2025device pma249d agoMedtronic Minimed, Inc. — Simplera Sync Sensor; Guardian 4 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 10, 2025device pma249d agoBiotronik, Inc. — Sentus ProMRI OTW QP S-75; Sentus ProMRI OTW QP S-85; Sentus ProMRI OTW QP S-95; Sentus ProMRI OTW QP L-75; Sentus ProMR (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 10, 2025device pma249d agoBoston Scientific Corp — WaveWriter Alpha™ Prime Spinal Cord Stimulation (SCS) Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    ›Dec 11, 2025device pma248d agoThe Cooper Companies — Biornedics 55 Asphere and Biornedies Torie (Ocuftlcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)COOPER COMPANIES, INC.

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

    full page →fda device pma ↗
    ›Dec 11, 2025device pma248d agoZoll Manufacturing Corporation — LifeVest® Wearable Defibrillator (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 11, 2025device pma248d agoMedtronic Minimed, Inc. — MiniMed 780G System (PMA supplement)Medtronic USA Inc

    Supplement type: Panel Track. Product code: OZP. Advisory committee: CH. Decision: APPR

    full page →fda device pma ↗
    ›Dec 11, 2025device pma248d agoZenflow, Inc. — Zenflow Spring® Implant and Delivery System (PMA)

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

    full page →fda device pma ↗
    ›Dec 11, 2025device pma248d agoMerit Medical Systems, Inc. — WRAPSODY® Cell-Impermeable Endoprosthesis (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Dec 11, 2025device pma248d 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 11, 2025device pma248d agoCooperVision, Inc. — Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 11, 2025device pma248d agoCerapedics, Inc. — PearlMatrix™ P-15 Peptide Enhanced Bone Graft (PearlMatrix™ Bone Graft) (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: NOX. Advisory committee: OR. Decision: APPR

    full page →fda device pma ↗
    ›Dec 12, 2025device pma247d agoAlcon Laboratories, Inc. — AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (PMA supplement)Alcon Laboratories Inc

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

    full page →fda device pma ↗
    ›Dec 12, 2025device pma247d agoETHICON, Inc. — SURGICEL® Absorbable Hemostats (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LMG. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Dec 12, 2025device pma247d agoMerz North America, Inc. — RADIESSE INJECTABLE IMPLANT (PMA supplement)

    Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

    full page →fda device pma ↗
    ›Dec 12, 2025device pma247d agoUrotronic, Inc. — Optilume™ BPH Catheter System (PMA supplement)

    Supplement type: 30-Day Notice. Product code: QXB. Advisory committee: GU. Decision: OK30

    full page →fda device pma ↗
    ›Dec 12, 2025device pma247d agoAlcon Research, Ltd. — AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (PMA supplement)Rubicon Research Ltd

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

    full page →fda device pma ↗
    $BSX51.83+0.27%
    $COO
    $MMSI90.76+0.29%
    $BSX51.83+0.27%
    $MDT91.27+0.76%
    $BSX51.83+0.27%
    $STAA26.18+3.36%