BEUDAMED
    20 results · 29ms · Sources: EU EUDAMED, US FDA

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    Halo

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768505·GENUMEDI PSS GREEN VI

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304240025·

    Femoral Cutting Block Posterior Capture

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215074418·

    PULSAVAC®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024375208·

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PROTECT TOOTH DESENSITIZER

    FDA 510(k)
    FDA Class 2 ·Dental

    X-SUIT NIR COVERED BILIARY METALLIC STENT

    FDA Adverse Event
    Malfunction ·MEDINOL LTD.·Product code FGE·December 27, 2017

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

    PARIETEX LIGHTWEIGHT MONOFILAMENT

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·June 16, 2011

    PINNACLE PELVIC FLOOR REPAIR KIT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FTL·September 5, 2008

    HIP KIT

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code FQH·December 4, 2019

    Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package, Zimmer Orthopaedic Surgical Products, Dover, Ohio

    FDA Recall
    Terminated ·Zimmer Orthopaedic Surgical Products·Product code FQH·December 18, 2007

    EOS PMP, EOS PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2021

    DIDECO EOS ECMO M PHISIO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·May 13, 2021

    SORIN LIFEKIT D905 EOS ECMO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 14, 2021

    EOS PMP, EOS PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·March 23, 2022

    PULS PLUS AC HIP KIT

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code FQH·November 25, 2019

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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