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

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    ACCUSCREEN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200181·Mand. 1. Molar band W-Fit left 18

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690112952·Retaining Bolt 18mm - PS/PS-C, primary tibia

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110935·STERILIZING CASE NARROW

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200180501·Mand. 1. Molar band W-Fit left 18

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200180051·Mand. 1. Molar band W-Fit left 18

    Matching Limb Protection Sleeves - Easi-Fit

    FDA UDI
    Delfi Medical Innovations Inc·M995979200181·Delfi Matching Limb Protection Sleeves (MLPS) h...

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89200180101·Mand. 1. Molar band W-Fit left 18

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867058132·UNIVERS TRIAL STEM, 8MM

    MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MINDCHILD MERIDIAN FETAL HEART RATE MONITOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·January 17, 2013

    PINN LNR CON +4 NEUT 28IDX50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWZ·December 3, 2010

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 8, 2014

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017