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

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    Saccade Analytics Inc.

    Manufacturer
    🇨🇦 Canada·1 Basic UDI-DI·1 Device

    RamSoft Inc.

    Manufacturer
    🇨🇦 Canada·11 Basic UDI-DIs·11 Devices

    Densitas Inc

    Manufacturer
    🇨🇦 Canada·2 Basic UDI-DIs·5 Devices

    PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.

    FDA Enforcement
    Class II ·Terminated·Zimmer CAS·December 10, 2014

    Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;

    FDA Enforcement
    Class II ·Terminated·Zimmer CAS·June 10, 2015

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·RamSoft Inc.·On the market·32 countries

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·RamSoft Inc.·On the market·32 countries

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·RamSoft Inc.·On the market·32 countries

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·RamSoft Inc.·On the market·32 countries

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·RamSoft Inc.·On the market·32 countries

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·RamSoft Inc.·On the market·32 countries

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·RamSoft Inc.·On the market·32 countries

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·RamSoft Inc.·On the market·32 countries

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·RamSoft Inc.·On the market·32 countries

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDD · Eu Md Class 1 ·RamSoft Inc.·On the market·32 countries

    RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES

    Device
    EU MDD · Eu Md Class 1 ·RamSoft Inc.·On the market·32 countries

    NeuroFlex

    Device
    EU MDR · Eu Md Class 1 ·Saccade Analytics Inc.·On the market·32 countries

    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

    FDA Enforcement
    Class III ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017

    SmartTools Knee System Orthopedic Stereotaxic Instrument

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 2017

    Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components

    FDA Enforcement
    Class II ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 3, 2017