BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    CARESCAPE MONITOR B450

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030568·AILERON Static Posterior Fusion Core, 13mm Slot...

    Aileron Posterior Fusion System

    FDA UDI
    Life Spine, Inc.·00190837030575·AILERON Static Posterior Fusion Plate, 13mm Slo...

    ROTATING GAMMA SYSTEM INFINI (INFINI)

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTELEPACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    ASR ACETABULAR IMPLANT 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD - 8010379·Product code KWA·May 29, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 17, 2011

    FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.

    FDA Enforcement
    Class II ·Terminated·Remington Medical Inc.·April 16, 2014

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023