BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    NUCLIPASE (I125) PANCREATIC LIPASE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TUCK-TITE COLON FLUID RETAINER

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 25, 2014

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·January 2, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·November 2, 2010

    MAGNUM HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·March 8, 2018

    UNKNOWN STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·March 8, 2018

    E-POLY LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·March 8, 2018

    CRUZ RT TRIFLANGE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·March 8, 2018

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017