BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROCEDURE, RED CELL FOLATE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 2, 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 4, 2024

    CONCERTO II CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTORNIK SE & CO. KG·Product code NVZ·November 29, 2012

    COOL PATH CATHETER 7F, 1304-CP-7-25-L

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL, IRVINE·Product code OAD·September 21, 2010

    GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·November 21, 2018

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012