BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

    FDA 510(k)
    FDA Class 2 ·Radiology

    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DATABASE MANAGEMENT & REPORTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code INK·March 7, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

    MYOCARDIAL LEAD

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·August 8, 2014

    Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

    FDA Enforcement
    Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018