BEUDAMED
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    SUR-FIT SYSTEM PRE-OPERATION SET

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    VITROS

    FDA UDI
    ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750006663·VITROS Chemistry Products Calibrator Kit 18

    Phantom Tibial Preparation

    FDA UDI
    ADLER ORTHO SPA·08052693623518·GENUS PANTHEON PHANTOM TIBIAL PREPARATION SZ.2

    Oph.Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668118122·Desmarres Chalazion Forceps, medium

    CARBOXYLATE CEM, PHOSPHATE CEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702

    FDA 510(k)
    FDA Class 2 ·Hematology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 8, 2014

    EPIC SELF-EXPANDING NITINOL STENT WITH DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code FGE·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 27, 2007

    BD PHASEAL¿ OPTIMA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FOZ·October 16, 2018

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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