BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    UROVISION JANUS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SANDMAN ELITE

    FDA 510(k)
    FDA Class 2 ·Neurology

    RESCUE IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ADVISA DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·February 9, 2013

    ARCHITECT STAT TROPONIN-I

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MMI·January 8, 2011

    KINETRA

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code MHY·July 23, 2014

    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3383-95, 3344-95, 3353-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3383-95, 3344-95, 3353-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Recall
    Terminated ·Westmed Inc·Product code CBT·January 18, 2011