BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    Needle's Eye Snare Retrieval Set - 54cm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CTBOX CERVICAL/LUMBAR TRACTION

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 3/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 1, 2020

    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

    COGNIS

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 15, 2011

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 11, 2013

    BD LOGIC BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORP·Product code CGA·July 16, 2014

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·July 7, 2017

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·July 7, 2017

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 22, 2018

    V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

    FDA Enforcement
    Class II ·Terminated·Vital Scientific N.V.·October 16, 2019

    RECLAIM DISTAL TAPERED 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

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016