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

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    WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Comprehensive® Shoulder System

    FDA UDI
    Biomet Orthopedics, LLC·00887868267710·

    COMPREHENSIVE SHOULDER SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304449763·

    ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·May 4, 2022

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 15, 2013

    R3 3 HOLE ACET SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDH·September 24, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL·Product code MKJ·May 24, 2011

    4.5 BROAD SCP PLT 26-H STER

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    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