BEUDAMED
    7 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.

    ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UNIVERSAL COMPRESSION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·February 22, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 4, 2014

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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