BEUDAMED
    10 results · 20ms · 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.

    GLUCOSE (GDH) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198970·AK3 Congruent Insert Trial Size 2, 13mm

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331157851·obwegeser soft tissue retractor, 8 3/4" (22.2 c...

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515329508·Boss Steinman Pin, 9", Threaded Single Diamond,...

    FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AIR ENRICHER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·May 5, 2014

    EXTERNAL PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·October 15, 2012

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 22, 2015

    PROPONENT DR SL (Model L201)

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