BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MIXING SYRINGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDLINE

    FDA Adverse Event
    Malfunction ·MEDLINE INDUSTRIES INC.·Product code OHR·August 25, 2021

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 20, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 18, 2013

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·November 2, 2016

    VANGUARD COMPLETE KNEE FEMUR RIGHT 60MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·February 27, 2025

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025