BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    OneTouch Via On-Demand Insulin Delivery System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221046116·Unitek(TM) Molar Band General Purpose Wide Hard...

    LIFEBRIDGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEPTH ELECTRODE

    FDA Adverse Event
    Malfunction ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·December 14, 2021

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·October 10, 2014

    IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·June 11, 2013

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTL. LTD.·Product code JDI·July 8, 2011

    COBAS 6000 E 601 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 10, 2017

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014