BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    JENSEN ZIRCONIA

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814572·GENUMEDI SAND SIZE VI

    Working Tube

    FDA UDI
    ELLIQUENCE, LLC·00846338006396·

    T-Crystal cartridges Clear

    FDA UDI
    PERFLEX LTD·07290110506261·5 identical cartridges sealed in a vacuum bag ;...

    GLOBAL

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295004943·GLOBAL FX STANDARD STEM SIZE 6 120mm

    GLOBAL

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295004950·GLOBAL FX REVISION STEM SIZE 6 160mm

    GLOBAL

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295004967·GLOBAL FX POROCOAT STANDARD STEM SIZE 6 120mm

    NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS

    FDA 510(k)
    FDA Unclassified ·Unknown

    CYNOSURE PHOTOGENICA VL

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

    22G X 1.0" BD INSYTE¿ AUTOGUARD¿ WITH BLOOD CONTROL TECHNOLOGY

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 23, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    22 G X 1 IN. (1.3 MM X 30 MM) BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 26, 2017

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·May 14, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 29, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·May 29, 2013

    Accu-Chek FlexLink 1 infusion set; 8/30; Ref number 04540778001. (Distributed outside of the U.S. only).

    FDA Recall
    Terminated ·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006

    cobas 8000 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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025