BEUDAMED
    22 results · 29ms · Sources: EU EUDAMED, US FDA

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    AXUS ES-5 Electro-Acupuncture Device

    FDA 510(k)
    FDA Unclassified ·Unknown

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00142006360·CC-316

    Olympus

    FDA UDI
    Gyrus ACMI, LLC·00821925047310·ES-IP iOR System - Mali

    djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.

    FDA Enforcement
    Class II ·Ongoing·Encore Medical, LP·April 22, 2020

    SPATULA OSTEOTOME 6MM

    FDA UDI
    W.H. Holden, Inc.·D9282006360·

    MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

    FDA Recall
    Terminated ·Product code LPH·June 21, 2016

    djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.

    FDA Recall
    Open, Classified ·Product code LPH·July 10, 2018

    MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636

    FDA Enforcement
    Class II ·Terminated·Encore Medical, Lp·July 27, 2016

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68120063600000·Left X-Ray Marker

    STRYKER TRAUMA PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AI-ECG Tracker

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRAVO

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code FFT·May 1, 2008

    BRAVO

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code FFT·May 1, 2008

    BRAVO

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code FFT·May 1, 2008

    BRAVO

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code FFT·May 1, 2008

    MINICAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·October 24, 2014

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·March 25, 2019

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021