BEUDAMED
    9 results · 17ms · 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.

    MODIFIED TRACHEAL TUBE WITH SALTZMAN E.A.R.(TM)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556700638·GC Initial™ MC Bleach Enamel BL-E, 50g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228702551·GC Initial™ MC Bleach Enamel BL-E, 50g

    NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Threshold™ V2 Pedicular Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 12, 2014

    PT²¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·December 12, 2012

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2015

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024