BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Hexanium® TLIF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF

    FDA 510(k)
    FDA Class 2 ·Neurology

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 4, 2020

    ESSURE

    FDA Adverse Event
    Malfunction ·BAYER PHARMA AG·Product code HHS·March 26, 2021

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 8, 2014

    TRUFIT BGS PLUG KITS

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW ENDOSCOPY·Product code MQV·October 22, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·December 19, 2012

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·August 24, 2020

    a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020