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

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    CapMedic

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304271722·

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515028920·Horgan Malleable Blade, 2 1/2"W x 6 1/2"L

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180175020·CIRCLE CLAMP ASSEMBLY

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304473157·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776390860·Circle Clamp Assembly

    IOS FASTSCAN SPRAY

    FDA 510(k)
    FDA Class 2 ·Dental

    I-FIX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·October 4, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CGA·July 8, 2011

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MIH·February 9, 2018

    TRUWAVE, VAMP

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025

    G7 PPS LTD ACET SHELL 54F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·January 15, 2018

    SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·August 14, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012