BEUDAMED
    10 results · 19ms · 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 ×

    LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    PROFEMUR® RENAISSANCE® CLASSIC STD FLARE SZ 12 V8D

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code JDI·May 23, 2022

    EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ISROBOT MONA LISA

    FDA 510(k)
    FDA Class 2 ·Radiology

    FOLYSIL SILICONE CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·August 24, 2023

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 14, 2021

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·January 11, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·November 23, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 3, 2014

    Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

    FDA Enforcement
    Class II ·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025