BEUDAMED
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    PHAKOSYSTEMS MODEL CES 4100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Zimmer CAS

    Manufacturer
    🇨🇦 Canada·1 Importer

    ZIMMER CAS

    FDA registration
    ZIMMER CAS·24 products·🇨🇦 Canada

    Armery Medical Technologies Inc.

    Manufacturer
    🇨🇦 Canada

    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

    CEMAR ELECTRO INC

    Manufacturer
    🇨🇦 Canada·1 Importer

    Kube Innovation Inc

    Manufacturer
    🇨🇦 Canada·5 Basic UDI-DIs·5 Devices·1 Importer

    Luméd inc.

    Manufacturer
    🇨🇦 Canada·1 Importer

    Turbomed Orthotics inc.

    Manufacturer
    🇨🇦 Canada·8 Basic UDI-DIs·44 Devices·2 Importers

    Les Equipements Adaptés PHYSIPRO INC

    Manufacturer
    🇨🇦 Canada

    Merrithew International Inc

    Manufacturer
    🇨🇦 Canada·9 Basic UDI-DIs·46 Devices·4 Importers

    OrthoPediatrics Canada ULC

    Manufacturer
    🇨🇦 Canada·143 Basic UDI-DIs·143 Devices·1 Importer

    Emovi inc.

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

    V2 Max Plus™ Reformer (ONYX) Bundle (with reg. Gearbar)

    Device
    EU MDR · Eu Md Class 1 ·Merrithew International Inc·On the market·29 countries

    V2 Max™ Reformer Bundle (ONYX) (with reg. Gearbar)

    Device
    EU MDR · Eu Md Class 1 ·Merrithew International Inc·On the market·29 countries

    V2 Max Plus™ Reformer (ONYX) Bundle with High Precision Gearbar

    Device
    EU MDR · Eu Md Class 1 ·Merrithew International Inc·On the market·29 countries

    Innobyte Bilateral Clinical Package

    Device
    EU MDR · Eu Md Class 1 ·Kube Innovation Inc·On the market

    Innobyte Bilateral Mouthpiece

    Device
    EU MDR · Eu Md Class 1 ·Kube Innovation Inc·On the market