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calendar

821 catalysts · 3,603 8k filing · 2,280 grant · 1,746 approval · 1,120 device 510k · 1,000 device adverse event · 821 device pma

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type: device pma×from 2025-12-08×clear all
type
  • 8k filing3,603
  • grant2,280
  • approval1,746
  • device 510k1,120
  • device adverse event1,000
  • device pma821
device recall
602
  • earnings585
  • recall266
  • phase 2 completion172
  • therapy area

    no tagged catalysts yet

    Week of Dec 8, 2025

    45
    ›Dec 8, 2025device pma264d 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 pma264d agoMedtronic, 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 pma264d 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 pma264d agoFlow Neuroscience AB — Flow FL-100 (PMA)

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

    full page →fda device pma ↗
    ›Dec 8, 2025device pma264d 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 pma264d 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 pma263d 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 pma263d 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 pma263d 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 pma263d 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 pma263d 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 pma263d 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 pma263d 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 pma263d 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 pma263d 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 pma263d agoProverum, Ltd. — ProVee System for BPH (PMA)

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

    full page →fda device pma ↗
    ›Dec 9, 2025device pma263d 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 pma262d 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 pma262d 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 pma262d 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 pma262d 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 pma262d 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 pma262d 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 pma262d 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 pma262d 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 pma261d 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 pma261d 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 pma261d 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 pma261d 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 pma261d 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 pma261d 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 pma261d 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 pma261d 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 pma260d 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 pma260d 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 pma260d 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 pma260d 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 pma260d 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 ↗
    ›Dec 12, 2025device pma260d agoAlcon Laboratories, LLC — Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL (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 pma260d agoMerz North America, Inc. — COAPTITE (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 12, 2025device pma260d agoTerumo Medical Corporation — MISAGO® RX Self-expanding Peripheral Stent (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 12, 2025device pma260d agoMedtronic Vascular, Inc. — Abre Venous Self-expanding Stent System (PMA supplement)

    Supplement type: Special (Immediate Track). Product code: QAN. Advisory committee: CV. Decision: APPR

    full page →fda device pma ↗
    ›Dec 12, 2025device pma260d agoETHICON, Inc. — INTERCEED™ Absorbable Adhesion Barrier (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30

    full page →fda device pma ↗
    ›Dec 12, 2025device pma260d agoMerz North America, Inc. — RADIESSE 1.3CC AND 0.3CC (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 12, 2025device pma260d agoBoston Scientific Corp — WATCHMAN FLX™ Left Atrial Appendage (LAA) Closure Device with Delivery System; WATCHMAN FLX™ Pro Left Atrial Appendage ( (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗

    Week of Dec 15, 2025

    5
    ›Dec 15, 2025device pma257d agoVentana Medical Systems, Inc. — PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PMA supplement)MERIT MEDICAL SYSTEMS INC

    Supplement type: Normal 180 Day Track. Product code: MVC. Advisory committee: PA. Decision: APPR

    full page →fda device pma ↗
    ›Dec 15, 2025device pma
    ← prev
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    257d ago
    Medtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 15, 2025device pma257d agoEBR Systems, Inc. — WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (PMA supplement)EBR Systems, Inc.

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

    full page →fda device pma ↗
    ›Dec 15, 2025device pma257d 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 15, 2025device pma257d agoBoston Scientific Corp — WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device with Delivery System (PMA supplement)BOSTON SCIENTIFIC CORP

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

    full page →fda device pma ↗
    $COO
    $BSX47.53-1.33%
    $MDT91.23+1.40%
    $MMSI90.54-0.60%
    $STAA22.11-1.25%
    $MMSI90.54-0.60%
    $BSX47.53-1.33%
    $BSX47.53-1.33%
    $EBRCZ0.2780+48.56%
    $BSX47.53-1.33%