BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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    F.R.C. APPARATUS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Acumed

    FDA UDI
    Provision·B504OM8010880·

    ACUMED

    FDA UDI
    Acumed LLC·10806378046421·3.0mm X 5" Quick Release Drill

    MYRAY SKYVIEW

    FDA 510(k)
    FDA Class 2 ·Dental

    ULTRASIM CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CHOLESTECH LDX

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code CHH·October 17, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 21, 2007

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2014

    PREVENT NEEDLE

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FMI·July 9, 2018

    VAPR3 FOOTSWITCH *EA

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HRX·June 27, 2019

    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

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

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

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

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