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

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    KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

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

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700661·GC Initial™ MC Dentin DD4, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556700959·GC Initial™ MC Dentin DD4, 20g

    Green16/Green18 (Model: PHT-65LHS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUANTA LITE RNA POL III ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    HOMECHOICE

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

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2010

    PRIM SYM SET 2 CL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·December 10, 2012

    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