BEUDAMED
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    INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NA

    FDA UDI
    STRYKER CORPORATION·07613327052251·Palpation Probe

    VISUALINE BARBITURATES DIPSTRIP TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DRIP ALERT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 14, 2024

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    FDA Adverse Event
    Injury ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·July 3, 2012

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

    OMNIDIAGNOST ELEVA

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZI·April 7, 2011

    DXTEND STAND PE CUP D38 +3MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.·Product code HSD·July 18, 2008

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.

    FDA Recall
    Terminated ·Alpha Omega Services Inc·Product code IWJ·November 15, 2007

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014