BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120306231·Diamond, cone round, medium grit

    Wireless Footswitch

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904089898·

    VANISHPOINT INSULIN SYRINGE U-100

    FDA Adverse Event
    Injury ·RETRACTABLE TECHNOLOGIES, INC.·Product code MEG·May 7, 2016

    SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    INTERACTIVE REAL TIME SCANNING PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    GORE DRYSEAL SHEATH

    FDA Adverse Event
    Injury ·W. L. GORE ASSOCIATES·Product code DYB·March 25, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER- SILICON VALLEY·Product code GEX·March 9, 2011

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS LLC·Product code MCM·April 16, 2008

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·July 25, 2011

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·July 9, 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

    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