BEUDAMED
    16 results · 30ms · Sources: EU EUDAMED, US FDA

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    COLTENE RAPID

    FDA 510(k)
    FDA Class 2 ·Dental

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700471·GC Initial™ MC Op. Dentin Mod. ODM-1, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556702304·GC Initial™ MC Op. Dentin Mod. ODM-1, 20g

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867317963·Ikuta Clamp

    NUNC IVF DISHES AND NUNC IVF 4-WELL DISH

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

    All-in-One Health Monitor, PC-303

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 28, 2014

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·October 15, 2010

    PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE

    FDA Adverse Event
    Malfunction ·INTEGRA NEUROSCIENCES PR·Product code JXG·December 10, 2012

    CER OPTION TYPE 1 TAPER SLEVE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·September 21, 2018

    M/H 3 HOLE RINGLOC SHELL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 21, 2018

    EPOLY 36MM RLC LNR MROM SZ25

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·August 6, 2018

    CER BIOLOXD OPTION HD 36MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·August 6, 2018

    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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020