BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    FusionFrame Ring Lock System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777600·LUMBAMED BASIC DORSAL STAY WM SILVER III

    INBONE

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420196354·Hex Key

    K-Wire

    FDA UDI
    Treace Medical Concepts, Inc.·00810111224413·1.4MM x 178MM K-WIRE

    SEE H10

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 15, 2022

    NAC Y-ADP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 23, 2021

    ENDOCARDIAL TINED LEAD

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS·Product code LWS·February 8, 2002

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 28, 2025

    T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·December 19, 2017

    LUMENIS ONE

    FDA Adverse Event
    Other ·LUMENIS LTD·Product code GEX·October 9, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    ESTELLA DR-T PROMRI

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code DXY·July 1, 2013

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014