BEUDAMED
    10 results · 20ms · 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 ×

    FLEXMATE K500

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MODIFICATION TO BVBLUE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DS Core Diagnosis

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCESSORIES

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025

    ABX MINOTROL 16

    FDA Adverse Event
    Other ·HORIBA MEDICAL·Product code GKZ·June 6, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·June 9, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 8, 2013

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

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