BEUDAMED
    8 results · 19ms · 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.

    AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Eko Foundation Analysis Software with Transformers (EFAST)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001

    FDA 510(k)
    FDA Class 2 ·Radiology

    TI COLLAR WITH GROOVES

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MNI·June 5, 2012

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·February 9, 2013

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 6, 2011

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 22, 2014

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

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