BEUDAMED
    174 results · 18ms · Sources: EU EUDAMED, US FDA

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    TMS Screwdriver

    Device
    EU MDR · Eu Md Class 1 ·My Implant Business GmbH·On the market·30 countries

    Easy Bone Collector Large

    Device
    EU MDR · Eu Md Class 2a ·My Implant Business GmbH·On the market·30 countries

    TMS Drill

    Device
    EU MDR · Eu Md Class 2a ·My Implant Business GmbH·On the market·30 countries

    TMS Drill TWOPAC

    Device
    EU MDR · Eu Md Class 2a ·My Implant Business GmbH·On the market·30 countries

    Easy Bone Collector Regular

    Device
    EU MDR · Eu Md Class 2a ·My Implant Business GmbH·On the market·30 countries

    Easy Bone Collector Small

    Device
    EU MDR · Eu Md Class 2a ·My Implant Business GmbH·On the market·30 countries

    Fixation System

    Device
    EU MDR · Eu Md Class 1 ·My Implant Business GmbH·On the market·30 countries

    TMS Drill

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·My Implant Business GmbH·2 devices

    Easy Bone Collector

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·My Implant Business GmbH·3 devices

    Fixation System

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·My Implant Business GmbH·1 device

    TMS Screwdriver

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·My Implant Business GmbH·1 device

    ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 13, 2014

    ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·March 21, 2018

    ORTHO-REHA Neuhof GmbH

    Importer
    🇩🇪 Germany·17 Manufacturers

    BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·February 19, 2014

    Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 20, 2014

    8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.

    FDA Enforcement
    Class II ·Ongoing·Stryker Leibinger GmbH & Co. KG·May 29, 2024

    Maxcert Eurep

    Authorized representative
    🇩🇪 Germany·65 Manufacturers·8 Devices

    ARCHITECT HAVAB-G Calibrator, REF 6L27-01

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·December 4, 2019

    PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·May 21, 2025