BEUDAMED
    8 results · 27ms · 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 ×

    Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SUNETICS CLINICAL BIO-STIMULATION LASER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ELECSYS PROBNP IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·November 6, 2014

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·July 19, 2011

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 18, 2013

    COOK SPECTRUM TURBO-JECT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·March 5, 2018

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025