BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    NOD CHEMISTRY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR20608501·Arch wires Titanol Budget max. .020"

    Klitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0603500·Tray, Base, 3.5"

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0604500·Tray, Base, 4.5"

    POLESTAR N-10

    FDA 510(k)
    FDA Class 2 ·Radiology

    GPF-29 GENERAL PURPOSE COIL SET

    FDA 510(k)
    FDA Class 2 ·Radiology

    Optetrak Logic

    FDA UDI
    Exactech, Inc.·10885862284914·LOGIC CC FEM STEM TRIAL SIZE 5 LEFT

    Truliant CC

    FDA UDI
    Exactech, Inc.·10885862626103·TRULIANT CC MODULAR FEMORAL STEM TRIAL SIZE 5 LEFT

    EEA 28MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·June 1, 2015

    EEA31

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GDW·August 31, 2015

    PREMIUM PLUS CEEA* 28 INSTR. W/TILT-TOP*

    FDA Adverse Event
    Injury ·COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN·Product code GDW·November 4, 2015

    SELOX ST 60

    FDA Adverse Event
    BIOTRONIK SE & CO. KG·Product code NVN·April 16, 2013

    PUMP IN STYLE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDELA, INC.·Product code HGX·March 11, 2011

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code GZB·August 6, 2014

    DST SERIES ORVIL AUTOMATIC 25MM DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GDW·April 25, 2016

    EEA 31MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO INC·Product code GAG·December 11, 2015

    EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 25, 2014

    BIOMET CRUCIATE TIBIAL TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 20, 2017

    CSF VALVE

    FDA Adverse Event
    Injury ·Product code JXG·October 19, 2016

    Contour¿ next GEN Blood Glucose Monitoring System

    FDA Enforcement
    Class II ·Ongoing·Ascensia Diabetes Care US, Inc.·July 26, 2023