BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    EZ-SCREEN CANNABINOID/COCAINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Mimics Medical

    FDA 510(k)
    FDA Class 2 ·Radiology

    KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    REPLY

    FDA Adverse Event
    Malfunction ·SORIN BIOMEDICA CRM S.R.L.·Product code NVZ·October 15, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·February 7, 2014

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·December 21, 2012

    Custom Breast Augmentation Pack, part number PSS2455(D

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 9, 2015

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017