BEUDAMED
    7 results · 26ms · 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.

    PRISMA DISPOSABLE MVR/STILETTO BLADE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    GAMMA GLUTAMYLTRANSFERASE REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES·Product code LZG·June 2, 2014

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP. MEDICAL DIV.·Product code FNL·October 13, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 16, 2012

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025