BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    COAGULATION CONTROL, LEVEL I

    FDA 510(k)
    FDA Class 2 ·Hematology

    REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 30, 2014

    ARCHITECT I2000SR ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·November 18, 2010

    DEPUY ASR XL FEM IMP SIZE 49

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 8, 2013

    VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001

    FDA Enforcement
    Class II ·Ongoing·Visionsense, Ltd.·November 30, 2022

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025