BEUDAMED
    15 results · 20ms · 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 ×

    LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

    ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    OPTIMESH 500E CEMENT RESTRICTOR

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

    AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 26, 2014

    CORNERSTONE-SR TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2024

    SM PLUS BTT/OVAL BALLOON DISSECTOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC·Product code GCJ·May 1, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·June 20, 2011

    CORNERSTONE-SR TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017

    CORNERSTONE-SR® TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025

    CORNERSTONE-SR® TI-COATED CAGE SYSTEM

    FDA Adverse Event
    Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 8, 2024

    VITEK® 2 AST-YS08 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code NGZ·January 11, 2018

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015