BEUDAMED
    9 results · 19ms · 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.
    Filters Regulation: Us FDA ×

    ZEUS IFA(TM) nDNA Test System, ZEUS dIFine

    FDA 510(k)
    FDA Class 2 ·Immunology

    TIBIAL NAIL, STANDARD T2 TIBIA 9X300 MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 12, 2012

    IUR FLUID MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EZ3D-I, E3

    FDA 510(k)
    FDA Class 2 ·Radiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 6, 2014

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·August 16, 2011

    AVAULTA SOLO SYTHETIC SUPPORT SYSTEM - POSTERIOR

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code FTL·July 12, 2013

    BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.

    FDA Enforcement
    Class II ·Terminated·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·December 28, 2016

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022