BEUDAMED
    13 results · 30ms · Sources: EU EUDAMED, US FDA

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    PolyLock Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    Synthes GmbH·10886982151667·2.4MM CANNULATED SCREW SHORT THREAD 19MM

    Diamond Orthopedic, LLC

    FDA UDI
    DIAMOND ORTHOPEDIC, LLC·B551DMD2117430·2.4mm, Cannulated Screw, Short Thd., 19mm

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF2118430·2.4mm Cannulated Screw, Short Thread, 19mm

    ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    GENZYME DIRECT-AMYLASE TEST REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·January 5, 2022

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 4, 2013

    CONEXA

    FDA Adverse Event
    Injury ·LIFECELL CORPORATION·Product code FTM·August 15, 2011

    *

    FDA Adverse Event
    Malfunction ·LASERSCOPE·Product code GEX·August 6, 2008

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·July 8, 2013

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025