BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    AxSOS 3 Ti; Stryker Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERTONE, MODEL PT-11

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FUNNEL GUIDE CATHETER MODEL G1020608

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·October 10, 2014

    HX2 TEMPERATURE MANAGEMENT SYSTEMM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·June 6, 2013

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·July 14, 2011

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014