BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    LAKE GASTROSTOMY TUBE

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

    OMEGA

    FDA UDI
    Stryker GmbH·07613154482511·Lid

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981142254·Mariner Instrument Tray 1, Level 1

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707051785·.022/045 U6R TBT/NC -10T 5 OFF

    TOTAL PSA MICROTITER ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 8, 2013

    COAGUCHEK® XS SYSTEM

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

    EXPRESS 4

    FDA Adverse Event
    Malfunction ·IRIS INTERNATIONAL·Product code JQC·May 6, 2014

    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