BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Bur PM2-95 80K Diam C Ø4.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055502978·

    Bur PM2-95 80K diamond coarse Ø4.0mm sterile

    FDA UDI
    Bien-Air Surgery SA·J00711003260011·

    Mirror™

    FDA UDI
    CAYENNE MEDICAL, INC.·M543100326·Tibial insert, flat (RM/LL-48x10mm)

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450316344·

    Femoral Trial

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215040987·

    Unimed

    FDA UDI
    Unimed Medical Supplies, Inc.·06936735477760·Invasive BP Adaptor Cable Schiller

    STELLATE GRIDVIEW

    FDA 510(k)
    FDA Class 2 ·Neurology

    WAKO AUTOKIT C3

    FDA 510(k)
    FDA Class 2 ·Immunology

    TGS UKA FEMORAL AND TIBIAL COMPONENTS

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·March 21, 2012

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 15, 2011

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 19, 2012

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 8, 2013

    M2A 38MM MOD HD -6MM NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·September 18, 2014

    UNK

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·May 13, 2011

    The Harris Products Group

    FDA UDI
    J. W. HARRIS CO., INC.·00850005066491·

    DELTAXSFT10 1.5MM X 1CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·September 22, 2021

    BONE SCREW Ø6,5 H.25MM

    FDA Adverse Event
    Malfunction ·LIMACORPORATE S.P.A.·Product code LPH·January 25, 2022

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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