BEUDAMED
    31 results · 22ms · Sources: EU EUDAMED, US FDA

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    UNIVERSAL OPAQUE

    FDA 510(k)
    FDA Class 2 ·Dental

    ThermoCool SF NAV

    FDA UDI
    Biosense Webster Inc·10846835009255·

    D-Fine Double Diamond™ Primary Polisher Refill #04

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001823·Dental burnisher

    D-Fine Double Diamond™ Primary Polisher Refill #04

    FDA UDI
    DEN-MAT HOLDINGS, LLC·00359883003609·Dental burnisher

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131504·MUA NR WP 2.0GH Str

    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code LPB·September 6, 2017

    THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·November 8, 2017

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0315040·Probe, 1.5 inch Ball, Lenke, Straight, Impaction

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089476565·

    ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TI-CORE FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857561052·Parallel Trial Size 9x28x9 mm

    COOK TURBO-FLO HD HEMODIALYSIS CATHETER TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MPB·December 19, 2016

    PELORIS RAPID TISSUE PROCESSOR

    FDA Adverse Event
    Malfunction ·LEICA BIOSYSTEMS MELBOURNE·Product code IEO·May 10, 2013

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (IRWINDALE)·Product code LPB·August 19, 2016

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·February 3, 2017

    Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'

    FDA Enforcement
    Class II ·Ongoing·Molnlycke Health Care, Inc·May 24, 2017

    SMARTABLATE

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·October 17, 2017