BEUDAMED
    40 results · 24ms · 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 ×

    PILLAR PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ULTIMA SMARTBELT, MODEL 0560

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 26, 2024

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 22, 2013

    UNKNOWN DEEP BRAIN STIMULATOR

    FDA Adverse Event
    Death ·MEDTRONIC NEUROMODULATION·Product code MHY·April 25, 2011

    V24/26 COMPONENT MONITORING SYSTEM

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code DRT·July 9, 2008

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 13, 2021

    REVITAN, PROXIMAL PART, CONICAL, UNCEMENTED, 75, TAPER 12/14

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code LZO·April 26, 2019

    cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·June 20, 2018

    BD TRUCOUNT TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GKZ·July 15, 2021

    REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/260

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·May 6, 2019

    REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 18/140

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·April 29, 2019

    REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 26/260

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·April 26, 2019

    REVITAN, PROXIMAL PART, CYLINDRICAL, UNCEMENTED, 65, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·April 29, 2019

    REVITAN, DISTAL PART, CURVED, UNCEMENTED, 20/200

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code KWA·February 13, 2019

    REVITAN, DISTAL PART, STRAIGHT, UNCEMENTED, 20/140

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·August 7, 2018

    BD TRUCOUNT¿ ABSOLUTE COUNTING TUBES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·November 30, 2023

    OPTAN, STEM, RIGHT, UNCEMENTED, 16, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·June 4, 2018

    REVITAN DIST. CURVED 16/200

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·October 5, 2018