BEUDAMED
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    MEDSTAR SYSTEM, MODELS 533-300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040160616·Channels Flex 21mm 30.06

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717107030·Gutta Percha Points, Taper .02, Size #35, 120pc...

    COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II

    FDA 510(k)
    FDA Class 2 ·Immunology

    EUPALAMUS DEFLECTABLE STYLET, MODEL 01545

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VKMO 78000 3 QUADROX-I HMO 70000+VHK7000

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

    VKMO 78000 #QUADROX-I HMO 70000+VHK7000

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWF·April 6, 2016

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·March 21, 2013

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·February 10, 2011

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·March 28, 2008

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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