BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    PORCELAIN PRIMER

    FDA 510(k)
    FDA Class 2 ·Dental

    IDI 200 GAMMA COUNTER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·August 18, 2021

    M2A-MAGNUM 42-50MM TPR INSRT-3 0/-3MMT1

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 3, 2020

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·April 9, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 25, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 20, 2012

    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