BEUDAMED
    18 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.

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0130140·Sagittal Bender, Right

    BLOCK CEMENT RESTRICTOR (CR) - TITANIUM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Diamond D

    FDA UDI
    Keystone Industries·H66810130141·Denture Acrylic HC Liquid

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193100777·EVOS Straight HA PEEK, 14mm x 8mm x 26mm, Flat ...

    Zavation

    FDA UDI
    Zavation LLC·00842166114807·TLIF 30, 6deg -14

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 5/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 7, 2022

    INSET 30

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 30, 2025

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0130100·Segmental Rod Reducer Assembly

    INSTANT-VIEW METHADONE URINE DIP STRIP TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SOMATOM EMOTION MS

    FDA 510(k)
    FDA Class 2 ·Radiology

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 15, 2024

    WECK HEMOLOK ML CLIPS 6/CART 84/BOX

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GDO·February 25, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code LWS·March 10, 2011

    REVITAN DIST. CURVED 18/200

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·August 11, 2014

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018