BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    TORQUEDRIVER WRENCH

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556700829·GC Initial™ MC Dentin DA3, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700531·GC Initial™ MC Dentin DA3, 20g

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867318014·Hohmann Retractor, Double Ended (6/10mm)

    EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Meridian PM

    FDA 510(k)
    FDA Class 2 ·Dental

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 12, 2014

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 15, 2010

    MODEL NOT SPECIFIED

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·December 12, 2012

    LAERDAL Silicone Resuscitator (LSR), Adult size, containing Intake/Reservoir Valve. Sold as Part Nos: 870050-Adult Basic w/o Mask in Carton; 870051-Adult Complete in Carton; 870052-Adult Standard with Adult Mask 4-5+ in Carton; 870053-Adult Complete in Compact Case; 870055-Adult Complete in Display Case; 875500-Adult Update Kit. Responsible firm on the label: Distributed in the U.S. by Laerdal Medical Corporation, Wappingers Falls, NY, Made in Norway.

    FDA Recall
    Terminated ·Laerdal Medical Corporation·Product code BTM·December 23, 2003

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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