BEUDAMED
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    SYNTHES STERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890109430·Zirlux Multi-Unit Abutment 1 mmH compatible wit...

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100430·Caddie Lid, Adjustable Cross Links

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·May 5, 2026

    NA

    FDA UDI
    STRYKER CORPORATION·07613153000723·7.0mm Straight Dermabrader Medium

    CEMEX SYSTEM GUN APPLICATION VERSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEDTRONIC EXTENDED INFUSION SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·May 19, 2025

    MEDTRONIC EXTENDED INFUSION SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·April 30, 2025

    IVENIX LARGE VOLUME INFUSION PUMP

    FDA Adverse Event
    Malfunction ·FRESENIUS KABI USA LLC·Product code FRN·August 22, 2024

    IVENIX INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·FRESENIUS KABI USA LLC·Product code FRN·August 22, 2024

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2013

    CRYSTALENS HD

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code NAA·March 4, 2011

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020