BEUDAMED
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    KPS-I, THE KIDNEY PERFUSION SOLUTION

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

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508312·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508305·

    STEVE MADDEN

    FDA UDI
    FGX INTERNATIONAL INC.·00193033508329·

    MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022

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

    CONTACT DETACH

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 30, 2026

    SECONDARY CHISEL 5MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code FZX·March 20, 2013

    WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·March 10, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

    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

    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