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

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    Capstone Control™ Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREERIDER MODEL LUGGIE MODEL 168-4IT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    METER C - OT BASIC ORIGINAL

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code CFR·January 29, 2002

    GORILLA/BABY GORILLA PLATING SYSTEM

    FDA Adverse Event
    Injury ·PARAGON 28, INC·Product code HRS·September 17, 2020

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 17, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 26, 2013

    COLLEAGUE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    TRUETRACK

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·October 3, 2018

    SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019