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

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    GOTTEX SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Endodontic Hand Instruments

    FDA UDI
    TULSA DENTAL PRODUCTS LLC·D71668610211·Senseus Flexofile Size 010 21mm

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694032889·EnCompass 21mm Drill Guide

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981138622·DTS Awl, 10mm

    ENTAKE STANDARD AND SAFETY PEG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HydroMARK Breast Biopsy Site Marker

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

    OT PING ENHANCED METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 7, 2010

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 3, 2012

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012