BEUDAMED
    13 results · 32ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    FETAL CALF SERUM

    FDA 510(k)
    FDA Class 1 ·Hematology

    ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Immunology

    6F MACH 1, MODEL 34356-XXX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·January 9, 2014

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·October 2, 2007

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 2, 2020

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·December 15, 2021

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·December 15, 2016

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 31, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·December 16, 2024

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·February 24, 2025

    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015