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

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    RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code OLO·April 25, 2014

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code NPJ·April 25, 2014

    BioCare Safety Needles

    FDA UDI
    BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"

    Biosens cartridges Clear

    FDA UDI
    PERFLEX LTD·07290110501570·box of 6 identical cartridges sealed in a vacuu...

    2430 BALLOON CONTROLLER

    FDA UDI
    HANS RUDOLPH, INC.·00874750008933·2430AF INFL 4BALLOON CTRL 230V

    T-Crystal cartridges Clear

    FDA UDI
    PERFLEX LTD·07290110500177·Box of 6 identical cartridges sealed in aluminu...

    Disc Prep

    FDA UDI
    Life Spine, Inc.·00190837089955·

    T-Crystal cartridges Clear

    FDA UDI
    PERFLEX LTD·07290110506070·5 identical cartridges sealed in a vacuum bag ;...

    AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 14, 2013

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 25, 2011

    RESTORATION MODULAR PROXIMAL BODY BOLT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code KWY·August 7, 2008

    TI LOW PROFILE SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 20, 2019

    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

    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 L131, ESSENTIO DR EL MRI Pacemaker

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