BEUDAMED
    59 results · 23ms · Sources: EU EUDAMED, US FDA

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    May Grünwald reagent

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CARLO ERBA Reagents S.A.S.·1 device

    May Grünwald reagent RS 2.5L

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CARLO ERBA Reagents S.A.S.·1 device

    May Grünwald reagent RS 500 mL

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CARLO ERBA Reagents S.A.S.·1 device

    May Grünwald reagent RS 4 x 2.5 L

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CARLO ERBA Reagents S.A.S.·1 device

    May Grünwald reagent RS 6 x 500 mL

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CARLO ERBA Reagents S.A.S.·1 device

    May Grünwald reagent RS 6 x 100 mL

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·CARLO ERBA Reagents S.A.S.·1 device

    The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics). ¿ The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data, via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format. The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·April 21, 2021

    Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    FDA Enforcement
    Class II ·Terminated·Fx Solutions·July 25, 2018

    Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    FDA Enforcement
    Class II ·Terminated·Fx Solutions·July 25, 2018

    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

    L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). L-Varlock Lumbar implants are to be used with autogenous bone graft and implanted via an open posterior approach. L-Varlock Lumbar implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

    FDA Enforcement
    Class II ·Terminated·Kiscomedica S.A.·March 22, 2017

    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.

    FDA Enforcement
    Class II ·Terminated·BIOMET FRANCE S.A.R.L.·June 17, 2015

    Dr Jay

    Device
    EU MDR · Eu Md Class 1 ·Dr Jay·On the market·32 countries

    I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175

    FDA Enforcement
    Class II ·Ongoing·In2Bones, SAS·March 27, 2024

    I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180

    FDA Enforcement
    Class II ·Ongoing·In2Bones, SAS·March 27, 2024

    sterEOS workstation

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·September 26, 2018

    UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.

    FDA Enforcement
    Class II ·Ongoing·Medicrea International·February 12, 2025

    Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons.

    FDA Enforcement
    Class I ·Terminated·MEDTECH SAS·November 13, 2019

    Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)

    FDA Enforcement
    Class II ·Ongoing·SCIENCE & BIO MATERIALS·May 14, 2025

    NucliSENS¿ Magnetic Extraction Reagents

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·October 31, 2018