BEUDAMED
    11 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.

    RAICHEM(TM) MAGNESIUM REAGENT, ENZYMATIC

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    RTM AND OVAL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DARI Health

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE

    FDA Adverse Event
    Malfunction ·SHERWOOD DAVIS AND GECK·Product code KNT·August 29, 1996

    M2A 38MMX54MM CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 27, 2021

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 30, 2014

    DRIVER - SPLIT HEXALOBE

    FDA Adverse Event
    Malfunction ·THEKEN SPINE·Product code HXX·October 4, 2010

    CANCELLOUS SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code DZL·December 20, 2012

    9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·July 26, 2017

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    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