BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OPUS 10 DENTAL DIODE LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AMS SLING FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 8, 2021

    VIPER 2 X-TAB 6X40MM TI

    FDA Adverse Event
    Injury ·DEPUY SYNTHES SPINE·Product code NKB·April 8, 2013

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 23, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2008

    Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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