BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    STEALTHSTATION SYSTEM UPDATE

    FDA 510(k)
    FDA Class 2 ·Neurology

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 14, 2019

    CART 9733856 S7 STAFF ASSEMBLED 110V

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019

    NAVLOCK UNIVERSAL GREEN TRACKER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 30, 2015

    SCREW DRIVER

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·August 5, 2019

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·May 18, 2018

    NAV THORACIC PROBE TIP

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code OLO·August 27, 2014

    NEUROLOGICAL STEREOTAXIC INSTRUMENT

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 26, 2015

    MAXITEX DUPLEX POWDER FREE LATEX STERILE SURGEON GLOVES PROTEIN LABELING CLAIM (50 MICRGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 13, 2017

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 13, 2017

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 7, 2016

    NDHP 0.2 MICRN HP CL

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·April 8, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·March 15, 2011

    QUICKSITE LV

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·February 2, 2021

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·February 11, 2021

    Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.

    FDA Enforcement
    Class II ·Terminated·Ondamed Inc·May 16, 2018