BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TORNIER AEQUALIS REVERSE SHOLDER PROSTHESIS

    FDA Adverse Event
    Malfunction ·TORNIER INC.·Product code HSD·June 18, 2009

    HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0

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

    DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)

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

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·July 25, 2018

    MED SYSTEMS ELECTRO FLO 5000 PERCUSSOR, 30 POWER/FREQUENCY SETTINGS AN

    FDA Adverse Event
    Injury ·MED SYSTEM, INC.·Product code BYI·September 21, 2018

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 3, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 28, 2011

    ASCENSIA BREEZE (US)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·April 15, 2008

    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    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