BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMNI LIFE SCIENCE, INC.·Product code KWY·April 13, 2009

    ECHOSCAN, MODEL US-1800

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APEX MODULAR HIP STEM

    FDA Adverse Event
    Injury ·OMNI LIFE SCIENCE, INC·Product code KWY·June 3, 2008

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    QUICK SET PARADIGM

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·October 27, 2009

    EXTENSION SET

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 11, 2011

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE DIABETES CARE AG·Product code LZG·July 2, 2013

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·April 18, 2014

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HRS·April 18, 2014

    PLATE,FIXATION,BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·February 15, 2019

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·February 15, 2019

    MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code NWJ·June 4, 2019

    MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code NWJ·June 4, 2019

    2.0MM HEX SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES TUTTLINGEN·Product code HXX·September 29, 2017

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016