BEUDAMED
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    BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221111821·3M™ Victory Series™ First Molar Bands, 902-267,...

    ELECSYS FERRITIN CALCHECK 5

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles

    FDA 510(k)
    FDA Class 2 ·Radiology

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 3, 2024

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 3, 2024

    MATTRESS COVER FOR MEDICAL PURPOSES

    FDA Adverse Event
    Injury ·UNKNOWN·Product code FMW·January 8, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 24, 2014

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 18, 2010

    BD PLASTIPAK 20ML SYRINGE LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 15, 2019

    BALL HEADS: MECTACER BIOLOX OPTION Ø 32

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 21, 2020

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017