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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 8, 2025

    24
    ›Dec 10, 2025device pma227d 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 pma227d 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 pma227d 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 pma227d 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 pma226d 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 pma226d 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 pma226d 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 pma226d 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 pma226d 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 pma226d 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 pma226d 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 pma226d 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 pma225d 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 pma225d 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 pma225d 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 pma225d 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 pma225d 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 pma225d 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 pma225d 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 pma225d 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 pma225d 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 pma225d 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 pma225d 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 pma225d 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

    26
    ›Dec 15, 2025device pma222d 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
    page 25 of 40
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    222d 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 pma222d 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 pma222d 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 pma222d 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 ↗
    ›Dec 15, 2025device pma222d agoUrotronic, Inc. — Optilume™ BPH Catheter System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 15, 2025device pma222d 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 ↗
    ›Dec 15, 2025device pma222d agoETHICON, Inc. — ETHIZIA (PMA)

    Product code: SGV. Advisory committee: SU. Decision: APPR

    full page →fda device pma ↗
    ›Dec 15, 2025device pma222d agoVentana Medical Systems, Inc. — HER2 Dual ISH DNA Probe Cocktail (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

    full page →fda device pma ↗
    ›Dec 15, 2025device pma222d agoMedibeacon, Inc. — MediBeacon® Transdermal GFR Measurement System (TGFR) (PMA supplement)

    Supplement type: Normal 180 Day Track. Product code: SDK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Dec 15, 2025device pma222d agoMedtronic, Inc. — Aurora EV-ICD System (PMA supplement)Medtronic plc

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

    full page →fda device pma ↗
    ›Dec 15, 2025device pma222d agoScibase AB — Nevisense (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 15, 2025device pma222d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D4, DVPB3D4; Cobalt XT MRI ICD DDPA2D4, DVPA2D4; Crome MRI ICD DDPC3D4, DVPC3D4; Evera MRI DF-1 ICD (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 15, 2025device pma222d agoRoche Molecular Systems, Inc. — COBAS HPV TEST (PMA supplement)

    Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoBard Peripheral Vascular, Inc. — LifeStent® Vascular Stent Systems (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoBausch & Lomb — Boston Orthokeratology (oprifocon A) (PMA supplement)Bausch & Lomb Corp

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

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoVistakon, Division of Johnson & Johnson Vision Car — VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoC.R. Bard, Inc. — Covera™ Vascular Covered Stent (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoTransMedics, Inc. — Organ Care System™ (OCS™) Liver (PMA supplement)TransMedics Group, Inc.

    Supplement type: Special (Immediate Track). Product code: QQK. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoJohnson & Johnson Surgical Vision, Inc. — Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hyaluronate Opht (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoMedtronic Vascular, Inc. — Protégé™ GPS™ Self-expanding Peripheral Stent System (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoBausch & Lomb — Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A) (PMA supplement)Bausch & Lomb Corp

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

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoCerenovus, Inc. — TRUFILL n-BCA Liquid Embolic System (LES), TRUFILL n-BCA Liquid Embolic System Procedural Set (PMA supplement)

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

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoTransMedics, Inc. — Organ Care System™ (OCS™) Lung System (PMA supplement)TransMedics Group, Inc.

    Supplement type: Special (Immediate Track). Product code: QBA. Advisory committee: GU. Decision: APPR

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoTransMedics, Inc. — Organ Care System™ (OCS™) Heart (PMA supplement)TransMedics Group, Inc.

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

    full page →fda device pma ↗
    ›Dec 16, 2025device pma221d agoJohnson & Johnson Surgical Vision, Inc. — TECNIS SIMPLICITY™ Delivery System (PMA supplement)JOHNSON & JOHNSON

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

    full page →fda device pma ↗
    $COO
    $BSX44.25+1.54%
    $MMSI74.32+1.66%
    $MMSI74.32+1.66%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $BSX44.25+1.54%
    $EBRCZ0.2780+48.56%
    $MMSI74.32+1.66%
    $JNJ263.40+1.59%
    $TMDX69.43-2.72%
    $MDT83.21+1.46%
    $BLCO16.17+1.19%
    $JNJ263.40+1.59%
    $BLCO16.17+1.19%
    $TMDX69.43-2.72%
    $TMDX69.43-2.72%
    $JNJ263.40+1.59%