BEUDAMED
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    DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUO

    FDA UDI
    FGX INTERNATIONAL INC.·00057800204930·

    QUO

    FDA UDI
    FGX INTERNATIONAL INC.·00193033442944·

    BIOZTECT SENSOR AND BIOZTECT CABLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RUSCH MILLER-ABBOTT TUBE

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

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 20, 2013

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code KWA·February 24, 2011

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·March 12, 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

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020