BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    EARLYSENSE CENTRAL DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COMBI-SCREEN, MODELS 10SL AND 11SL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·December 3, 2015

    ASR ACETABULAR IMPLANT 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 22, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 27, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020