BEUDAMED
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    IMMUNO. IDENTIFICATION OF H. CAPSULATUM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Bardia® Foley Catheter Insertion Tray

    FDA UDI
    C. R. Bard, Inc.·00801741018275·Bardia® Foley Catheter Insertion Tray

    NIR BILIARY STENT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    VIDAS® TOXO IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LGD·June 9, 2017

    VIDAS® TOXO IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LGD·June 15, 2017

    VIDAS® TOXO IGM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, S.A.·Product code LGD·June 13, 2017

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·October 23, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 28, 2015

    BD PHASEAL¿ PROTECTOR P50

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·October 17, 2018

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024