BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    AMERLEX CORTISOL RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RIVA CEM

    FDA UDI
    SDI LIMITED·09336472032203·RIVA CEM 1 SYR KT

    Preat

    FDA UDI
    Preat Corporation·00842092140284·Sphero Block Implant Abutment (Regular 2.5mm)

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517363534·CoRoent Small Tamp, Implant

    DUOFLO CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    COMP RVRS 25MM BSPLT HA+ADPTR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·May 19, 2021

    VERSANAIL TIBIOTALOCALCANEAL ANKLE FUSION NAIL

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HSB·April 15, 2017

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007

    UNKNOWN TRAUMA FIXATION SCREW

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HWC·May 16, 2018

    ATTUNE FB TIB BASE SZ 4 CEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·January 15, 2026

    UNKNOWN DISTAL LOCKING SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXT·January 29, 2014

    Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures.

    FDA Recall
    Terminated ·MCKESSON TECHNOLOGIES INC·Product code BRY·July 22, 2013

    GSI Audera (version 2.6 software) Viasys Healthcare, Inc. Part or (Catalog) Numbers: 2001-9700, 2001-9705, 2001-9715, 2001-9720 and 2001-9725. The GSI Audera is used as part of an audiometric test battery. It can be used to assess cochlear function, enable estimation of behavioral hearing thresholds by evoking auditory brainstem or steady state brainstem response and to aid in detection of lesions in the auditory pathway on neonates through adults.

    FDA Recall
    Terminated ·Cardinal Health, Inc·Product code EWO·September 16, 2008

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021