BEUDAMED
    1,793 results · 48ms · 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 ×

    Work Inc.

    FDA UDI
    WORK INCORPORATED·00860110000303·

    ZILVER PTX 35 DRUG-ELUTING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIU·March 20, 2018

    Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals.

    FDA Enforcement
    Class II ·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·January 13, 2016

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·October 25, 2018

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code MIH·June 13, 2018

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·July 12, 2019

    FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch (28.5 cm). The FlexFlow Venous Cannula is an open lumen polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple openings to allow increased fluid flow. The clear proximal section is not reinforced to allow clamping the proximal end that terminates in a 3/8 inch (9.5 mm) barbed connector for standard cardiopulmonary bypass tubing. Each cannula is furnished with a mated obturator. Each obturator has a malleable wire. Each component is packaged inside a protective sheath in a single sterile, sealed pouch

    FDA Enforcement
    Class II ·Terminated·Sorin Group USA, Inc.·November 15, 2017

    VIA WOUND VAC

    FDA Adverse Event
    Injury ·KCI·Product code OMP·April 11, 2012

    LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE

    FDA Adverse Event
    Death ·WILLIAM COOK EUROPE·Product code DQX·October 20, 2017

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code MQR·May 31, 2018

    PROCEED VENTRAL PATCH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·January 20, 2015

    ZILVER PTX 35 DRUG-ELUTING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIU·June 21, 2018

    C-QUR EDGE

    FDA Adverse Event
    Injury ·ATRIUM MEDICAL CORPORATION·Product code FTL·January 7, 2020

    TRI-STAPLE 2.0

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·October 1, 2018

    TROCHANTERIC NAIL KIT, TI 11X180MM X 130

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·January 31, 2012

    ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·June 12, 2018

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·March 20, 2018

    ZILVER PTX 35 DRUG-ELUTING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code NIU·August 23, 2017

    SAVVY LONG

    FDA Adverse Event
    Malfunction ·CLEAR STREAM·Product code LIT·November 18, 2008

    GC FUJITEMP LT

    FDA Adverse Event
    Malfunction ·GC CORPORATION·Product code EMA·July 28, 2011