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

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    THE MOSES ELITE APPLIANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCESS THYROGLOBULIN ANITBODY

    FDA 510(k)
    FDA Class 2 ·Immunology

    GEM-TONE BODY TRAINING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 29, 2014

    BMT GB KNEE STM 12X40

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code OIY·June 1, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAW·January 23, 2009

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAW·January 23, 2009

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAW·January 23, 2009

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·October 1, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 29, 2013

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 17, 2011

    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