BEUDAMED
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    ACID PHOSPHATASE REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTELLIVUE INFO CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023

    TRILOGY O2

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·May 7, 2014

    LARGE NEEDLE DRIVER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·January 8, 2013

    BIOLOX DELTA HEAD, 12/14, 32 X 0

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·November 11, 2010

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023

    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