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

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    ePTFE-Coated Auricular Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NAVIGATOR APPLICATIONS SUITE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO HYPERQ SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORIGEN BIOMEDICAL DUAL LUMEN 13FR CATHETER

    FDA Adverse Event
    Injury ·ORIGEN·Product code DWF·June 9, 2015

    SYMBIQ SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 5, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 17, 2011

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 25, 2008

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQO·January 18, 2019

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·November 26, 2019

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·November 26, 2025

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014