BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    DISTAT ANTI-DSDNA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACS ADVANCED CONCEPT GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTL, LTD.·Product code KWA·November 19, 2010

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NIK·July 1, 2014

    Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·August 12, 2020

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    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