BEUDAMED
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    PUMP TUBING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Leksell Stereotactic System

    FDA UDI
    Elekta Instrument AB·07340048311526·STERILIZING TRAY FOR G FRAME KIT

    READERS CHOICE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033511275·

    READERS CHOICE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033511268·

    READERS CHOICE

    FDA UDI
    FGX INTERNATIONAL INC.·00193033511251·

    TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    M2376A DEVICELINK SYSTEM, MODEL M2376A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 20, 2013

    OT ULTRA EASY METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 10, 2011

    EXETER V40 STEM 44MM NO 1

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CAEN·Product code KWY·March 13, 2008

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015