BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    ARCHITECT STAT CK-MB IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    JEDMED

    FDA UDI
    JEDMED INSTRUMENT COMPANY·M6330415960·HEADREST KIT FULLY ARTIC F/ JII&SII

    LIFERX

    FDA 510(k)
    FDA Class 2 ·Radiology

    UREA NITROGEN (BUN) LIQUID REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·November 29, 2017

    TITAN TOUCH

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FHW·July 13, 2022

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·April 8, 2013

    VITALITY AVT

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    SELUTE PICOTIP

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 6, 2011

    IMPLANT HOLDER-SLOT

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·November 12, 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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013