BEUDAMED
    231 results · 17ms · 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: Germany ×

    BAG Diagnostics GmbH

    Manufacturer
    🇩🇪 Germany

    Polaris GmbH

    Authorized representative
    🇩🇪 Germany·2 Manufacturers

    FAP-First Aid Products GmbH

    Importer
    🇩🇪 Germany

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    FAC

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

    PureMDR GmbH

    Authorized representative
    🇩🇪 Germany·9 Manufacturers·21 Devices

    AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

    FDA Enforcement
    Class II ·Ongoing·Aesculap AG·October 8, 2025

    AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.

    FDA Enforcement
    Class II ·Ongoing·Aesculap AG·October 8, 2025

    ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED 49973B ET DATA PREP / REVIEW SYSTEM 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·May 7, 2014

    ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·June 11, 2014

    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

    The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·March 4, 2015

    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