BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    NU-BORN BABY BATH KIT

    FDA 510(k)

    ACUMED

    FDA UDI
    Acumed LLC·10806378102295·1.7 Nm Torque Limiting Quick Connect

    QUEST MPS BACK-UP SYSYEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEBED PATIENT VIGILANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 5, 2007

    PROMETRA PROGRAMMABLE PUMP

    FDA Adverse Event
    Malfunction ·FLOWONIX MEDICAL, INC.·Product code LKK·February 21, 2014

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS·Product code GEX·October 19, 2012

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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

    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