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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Tempus ECG-AF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STARLUX PULSED LIGHT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025

    LYNX ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025

    LYNX ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025

    UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JLW·September 2, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    RONG ANGL-UPWARDS W/4 L330

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTX·July 18, 2013

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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