BEUDAMED
    12 results · 23ms · 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 ×

    Disposable Surgical Isolation Gown

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CRAG LATERAL FLOW ASSAY (LFA)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    K-ASSAY D-DIMER CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    UNKNOWN·Product code IKX·October 30, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

    PERITX DRAINAGE BAG KIT

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·December 18, 2025

    PERITX DRAINAGE BAG

    FDA Adverse Event
    Malfunction ·CAREFUSION, INC·Product code PNG·April 11, 2026

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023