BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: France ×

    ALN Pre-Curved RS

    Device
    EU MDD · Eu Md Class 3 ·ALN·On the market·11 countries

    Armatures pré-soudées au laser (Armatures inférieures inversées)

    Device
    EU MDR · Eu Md Class 2a ·Pul Concept·On the market·1 country

    Armatures pré-soudées au laser (Armatures inférieures standard)

    Device
    EU MDR · Eu Md Class 2a ·Pul Concept·On the market·1 country

    AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS

    Device
    EU IVDR · Eu Ivd Class A ·SIDENA·On the market·3 countries

    Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

    FDA Enforcement
    Class II ·Ongoing·Tornier S.A.S.·May 14, 2025

    Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery

    FDA Enforcement
    Class II ·Ongoing·Blue Ortho·October 30, 2024

    The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired instrument placement and performance is defined relative to the target anatomy. During the guidance phase, the device enables to monitor respiratory levels and verify patient position prior to instrument advancement. During the assessment phase, the achieved instrument placement and performance are displayed relative to the previously defined plan through an overlay of the pre- and post-treatment image data.

    FDA Enforcement
    Class II ·Completed·QUANTUM SURGICAL SAS·October 16, 2024

    ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate.

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·June 13, 2018

    BOUTIQUE PRO MEDICAL

    Authorized representative
    🇫🇷 France

    PROCESS FOR PRF

    Authorized representative
    🇫🇷 France·1 Manufacturer

    BOUTIQUE PRO MEDICAL

    System producer
    🇫🇷 France

    BIOLYS

    Importer
    🇫🇷 France·2 Manufacturers

    BIOSYNEX

    Importer
    🇫🇷 France·19 Manufacturers

    France Chirurgie Instrumentation SAS

    Importer
    🇫🇷 France·13 Manufacturers