BEUDAMED
    49 results · 25ms · Sources: EU EUDAMED, US FDA

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    PATIENT ISOLATION UNIT, MODEL G019-1000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROFYLE

    FDA UDI
    Stryker GmbH·04546540251831·Countersink, Stryker-Shaft

    Conformis Hip System

    FDA UDI
    Conformis, Inc.·00850268007866·ITOTAL HIP INSTRUMENT CASE

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014604619·SHOULDER PAD, RECTANGLE 9"X4"X2" DELUXE WITH VE...

    GUIDANT AXIUS CORONARY SHUNT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CUSTOM TUBING - SET INC. OXYGENATOR

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·April 24, 2015

    QUADROX COMPLETE PACK

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·November 24, 2014

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DWF·July 13, 2015

    QUADROX-I HMO 70000+VHK70000

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 7, 2015

    HMO 71000-J#QUADROX-1 ADULT + FILTER

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 3, 2015

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DWF·July 16, 2015

    HQC 16602-3#HL-SET, OFFENES SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·December 19, 2014

    DESCRIPTION FROM THE CUSTOMER REPORT:

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 19, 2016

    QUADROX-I ADULT WITH INTEGRATED FILTER

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·August 17, 2016

    CUSTOM TUBING - SET INCL. HMO 71000

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·April 14, 2015

    Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. The Chromophare surgical lights consist of a ceiling tube, SK Box swivel arm support, and a light head. The light head is mounted on a cardanic suspension unit and can be turned, swiveled and tilted in any direction. The spatial repositioning of the light head makes use of the 360 degree rotating swivel/horizontal arm. The 360 degree rotating spring arm is used to adjust the height. The light can be mounted in several configurations, such as a single/dual ceiling mount, a boom-integrated suspension mount, a wall mount, or a mobile roll stand.

    FDA Enforcement
    Class II ·Terminated·Stryker Communications·March 7, 2018

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 6, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·July 17, 2008