BEUDAMED
    23 results · 31ms · Sources: EU EUDAMED, US FDA

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    Advanced Algorithms for Treatment Management Applications (AATMA)

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Synthes GmbH·10886982152251·5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE...

    Fibula Plate PROlock

    FDA UDI
    I.T.S. GmbH·09120034302657·Fibula Plate PROlock, 8-Hole, Right

    ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·August 5, 2021

    BD VACUTAINER® SST¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·April 18, 2025

    BD VACUTAINER® SST¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·April 18, 2025

    MEDTRONIC HALL PROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES, INC.·Product code LWQ·June 18, 1997

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING / STANDARD 44MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWS·August 15, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

    ATTAIN STABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code OJX·April 19, 2021

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·September 6, 2018

    ATTAIN STABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code OJX·April 19, 2021

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 6, 2015

    APPLIANCE,FIXATION,NAIL

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·May 10, 2019

    PLATE,FIXATION,BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·May 10, 2019

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·May 10, 2019

    SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024