BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    AcQCross Qx Integrated Transseptal Dilator/Needle

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    InSitu Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127029936·Bipolar Head Assembly, Size 47mm

    RUBICOR BREAST BIOPSY DEVICE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CORAL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 31, 2008

    SETROX S 53

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO., KG·Product code NVZ·July 13, 2011

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012