BEUDAMED
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    SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Flexitron

    FDA UDI
    Nucletron B.V.·08717213026988·Flexitron Transfer Tube for 4F Flexibles (7)

    RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HSB·February 11, 2016

    GUARDIAN ROLLING WALKER

    FDA Adverse Event
    Malfunction ·A&E·Product code ITJ·November 4, 2008

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 14, 2013

    AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·August 13, 2008

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 30, 2019

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021