BEUDAMED
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    MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040014332·Zirlux 16+ D4 98.5X22

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964153310·Endo Carry-on Procedure Kit contains Intercept ...

    CLASSIC CEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ICG MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS, INC.·Product code QFG·May 8, 2026

    SOLETRA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION.·Product code MHY·March 1, 2012

    VALVE HANCOCK II MITRAL 31MM

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·May 13, 2016

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007

    DEROYAL

    FDA Adverse Event
    Other ·DEROYAL INDUSTRIES, INC.·Product code KDD·March 15, 2013

    MULTI-LINK OTW VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·March 8, 2011

    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