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

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    NeuroTrigger Basic (NTB)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PROFYLE

    FDA UDI
    Stryker GmbH·04546540259271·Screwdriver Blade

    Spex

    FDA UDI
    SPEX LIMITED·09420051700987·Spex 2 Point Padded Hip Belt, Dual Centre Pull,...

    CAPSTONE(R) SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PREG-Q EARLY PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    IDENTITY DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 10, 2011

    OPTIBOND SOLO PLUS

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code KLE·July 12, 2013

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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