BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ZenFlex

    FDA UDI
    Kerr Corporation·00195062029714·Rotary Files

    RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

    REPLY

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA S.R.L.·Product code NVZ·June 14, 2013

    PROTIME MICROCOAGULATION SYSTEM

    FDA Adverse Event
    Malfunction ·INTERNATIONAL TECHNIDYNE CORP.·Product code GKP·July 6, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 28, 2023

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·May 7, 2024

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·August 21, 2023

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL, INC.·Product code KRD·November 19, 2021

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 16, 2024

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 27, 2024

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL·Product code KRD·October 1, 2024

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL, INC.·Product code KRD·June 19, 2025

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 9, 2021

    IMPEDE-FX EMBOLIZATION PLUG

    FDA Adverse Event
    Malfunction ·SHAPE MEMORY MEDICAL INC.·Product code KRD·November 10, 2023

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024