BEUDAMED
    16 results · 26ms · Sources: EU EUDAMED, US FDA

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    KONICA DIRECT DIGITIZER REGIUS MODEL 350

    FDA 510(k)
    FDA Class 2 ·Radiology

    Diamond D

    FDA UDI
    Keystone Industries·H66810130541·Denture Acrylic SC Light Pwd

    CosmoLock Pedicle Screw System

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

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033454169·

    AUTOSTAT II ENA-6 PROFILE ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    12/14 ARTICUL 40MM M SPEC+8.5

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. 8010379·Product code LPH·March 20, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·March 4, 2011

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 15, 2014

    EVIS LUCERA COLONOVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDF·May 1, 2023

    UNKNOWN HUMERAL STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·May 13, 2021

    UNKNOWN GLENOID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·May 13, 2021

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    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

    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