BEUDAMED
    11 results · 26ms · 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.

    ZARA ZONE IV MALAR IMPLANT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377069443·RELINE C Screw, 4.0x16mm FA

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193119748·HA PEEK EVOS Straight, ,16mmx9mmx 22mm , FLAT 5...

    WARMTOUCH COMPACT WARMING UNIT

    FDA Adverse Event
    Malfunction ·COVIDIEN/FORMERLY TYCO·Product code DWJ·December 23, 2010

    ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    15L Cycler Drainage Bag

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

    WARM TOUCH II COMPACT WARMING UNIT

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DWJ·September 24, 2010

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·January 14, 2013

    PARADIGM INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·November 19, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ITI·July 3, 2014

    WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·April 22, 2015