BEUDAMED
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    EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR

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

    VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V

    FDA 510(k)
    FDA Class 2 ·Neurology

    DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRECISION?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 5, 2026

    ETEST DAPTOMYCIN DPC 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code JWY·October 30, 2020

    ETEST DAPTOMYCIN DPC 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX SA·Product code JWY·October 30, 2020

    INSERTER-LARGE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·April 29, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 11, 2014

    ACC-CHEK ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code FPA·July 25, 2008

    SURSHIELD PUR SAFETY I.V. CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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