78 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Germany
×
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
FDA Enforcement
Class II
·Ongoing·Brainlab AG·March 22, 2023
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Biomedical GmbH·September 30, 2020
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
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
BONA Mulltupfer 15er
Device
EU MDR
·
Eu Md Class 1
·Wilhelm Weisweiler GmbH & Co. KG·On the market·32 countries
MASTAZYME™ ANA Screen
Device
EU IVDD
·
Eu Ivd General
·Mast Diagnostica GmbH·On the market·1 country
ANA EL 200-100
Device
EU MDR
·
Eu Md Class 1
·BEKA-Hospitec GmbH·On the market·32 countries
ANA EL 180-100
Device
EU MDR
·
Eu Md Class 1
·BEKA-Hospitec GmbH·On the market·32 countries
ANA EL 140-100
Device
EU MDR
·
Eu Md Class 1
·BEKA-Hospitec GmbH·On the market·32 countries
ANA EL 200-80
Device
EU MDR
·
Eu Md Class 1
·BEKA-Hospitec GmbH·On the market·32 countries
ANA EL 100-80
Device
EU MDR
·
Eu Md Class 1
·BEKA-Hospitec GmbH·On the market·32 countries
ANA EL 180-80
Device
EU MDR
·
Eu Md Class 1
·BEKA-Hospitec GmbH·On the market·32 countries
ANA EL 140-80
Device
EU MDR
·
Eu Md Class 1
·BEKA-Hospitec GmbH·On the market·32 countries
BONA Wattekügelchen 9 mm
Device
EU MDR
·
Eu Md Class 1
·Wilhelm Weisweiler GmbH & Co. KG·On the market·32 countries
BONA Wattekügelchen 7 mm
Device
EU MDR
·
Eu Md Class 1
·Wilhelm Weisweiler GmbH & Co. KG·On the market·32 countries
BONA Wattekügelchen 5,5 mm
Device
EU MDR
·
Eu Md Class 1
·Wilhelm Weisweiler GmbH & Co. KG·On the market·32 countries
BONA Wattekügelchen 4 mm
Device
EU MDR
·
Eu Md Class 1
·Wilhelm Weisweiler GmbH & Co. KG·On the market·32 countries
BONA Wattekügelchen 3 mm
Device
EU MDR
·
Eu Md Class 1
·Wilhelm Weisweiler GmbH & Co. KG·On the market
BONA Wattekügelchen 2,7 mm
Device
EU MDR
·
Eu Md Class 1
·Wilhelm Weisweiler GmbH & Co. KG·On the market·32 countries
BONA Wattekügelchen 7 mm
Device
EU MDR
·
Eu Md Class 1
·Wilhelm Weisweiler GmbH & Co. KG·On the market·32 countries