BEUDAMED
    8 results · 33ms · Sources: EU EUDAMED, US FDA

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    IDS STAPHYLOCHROME TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    2M8101 HEATED LIQUID LEVEL CONTROLLER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    IR SLA Type Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 20, 2014

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 1, 2010

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024