BEUDAMED
    25 results · 34ms · 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.

    APPOSE ULE STERILE DISPOS. SKIN STAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117438·Modular Knee Stem Pilot 17mm x 75mm

    Zio AT® device (A100A1001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDOS HILITE OXYGENATOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·October 17, 2025

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·November 24, 2025

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·January 21, 2026

    INZII RETRIEVAL

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code GCJ·May 23, 2014

    MYNX CADENCE VASCULAR CLOSURE DEVICE 5F

    FDA Adverse Event
    Malfunction ·ACCESSCLOSURE, INC.·Product code MGB·June 22, 2012

    ZOLL DEFIBRILLATOR PADS

    FDA Adverse Event
    Malfunction ·DIXIE MEDICAL INC.·Product code MKJ·September 14, 2010

    The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 14, 2026

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·December 23, 2025

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·November 13, 2025

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·August 20, 2025

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·April 20, 2026

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·December 4, 2025

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·November 12, 2025

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·October 9, 2025

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·October 1, 2025

    ELECSYS ANTI-TSHR

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JZO·October 29, 2025