BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    21HQ613D

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD Difco™ QC Antigen Shigella Group D

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902210610·Vial Qc Antigen Shigella Grp D 1Ml

    FareTec Wheeled Litter Carrier

    FDA UDI
    FARETEC, INC.·B54122210610·FareTec WLC, Military, with extended basket clamps

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111317194·TISSUE FCP 1X2, 4 1/2" DEL

    IQ FLEX M

    FDA Adverse Event
    Malfunction ·FIRST SOURCE INC.·Product code IZL·May 29, 2024

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECISION XTRA

    FDA Adverse Event
    Injury ·Product code NBW·August 23, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 3, 2014

    UNKNOWN DEPUY FEMORAL HEAD

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KXA·July 11, 2013

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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