BEUDAMED
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    FUJIREBIO DIAGNOSTICS CA 19-9 RIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040160890·Channels Flex 25mm 60.04

    APC™ PLUS Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221093561·Mini Uni-Twin(TM) Bracket APC(TM) PLUS L4 -11T/...

    APC™ II Unitek™ Mini Uni-Twin

    FDA UDI
    3M UNITEK CORPORATION·00652221062543·Mini Uni-Twin(TM) Bracket APC(TM) II L4 -11T/0A...

    MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Immunology

    LUMALITE CURE LIGHT, MODEL 2100

    FDA 510(k)
    FDA Class 2 ·Dental

    LUMA ARCH

    FDA Adverse Event
    Injury ·LUMALITE, INC.·Product code EEG·July 6, 2004

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·March 26, 2013

    CARDIO VASCULAR SYSTEM

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZI·February 10, 2011

    ONYX

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·July 22, 2025

    Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 17, 2019

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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