BEUDAMED
    7 results · 28ms · 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.

    Planmed Clarity 2D and Clarity S

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IQ VENTILATION NASAL MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    QUARTET

    FDA Adverse Event
    Malfunction ·ST. JUDE EMDICAL, INC, CRMD·Product code DTS·January 11, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 27, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 4, 2011

    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