23 results
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20ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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VenSure Balloon Device, VenSure Nav Balloon Device
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.
FDA Enforcement
Class II
·Terminated·Brainlab AG·November 11, 2015
VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
FDA Enforcement
Class I
·Terminated·Brainlab AG·January 27, 2016
Drug-Screen SPC 50 Test
Device
EU IVDD
·
Eu Ivd General
·nal von minden GmbH·On the market·32 countries
NADAL Strep A Test
Device
EU IVDD
·
Eu Ivd General
·nal von minden GmbH·On the market·32 countries
NADAL Strep A Test
Device
EU IVDD
·
Eu Ivd General
·nal von minden GmbH·On the market·32 countries
NADAL® Malaria Pf/Pan Ag 4 Species Test
Device
EU IVDD
·
Eu Ivd General
·nal von minden GmbH·On the market·32 countries
RSS III
Device
EU IVDR
·
Eu Ivd Class A
·nal von minden GmbH·On the market
NADAL TPHA Microplate Haemagglutination Test
Device
EU IVDD
·
Eu Ivd General
·nal von minden GmbH·On the market
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
FDA 510(k)
FDA Class 2
·Anesthesiology
PoET HAV
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH·1 device
NADAL Strep A Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·nal von minden GmbH·1 device
NADAL Strep A Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·nal von minden GmbH·1 device
RSS III
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·nal von minden GmbH·1 device
NADAL TPHA Microplate Haemagglutination Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·nal von minden GmbH·1 device
Drug-Screen SPC 50 Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·nal von minden GmbH·1 device
NADAL Malaria Pf/Pan Ag 4 Species Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·nal von minden GmbH·1 device
HX 1034230-1
Certificate
IVDR QMS·nal von minden GmbH·TÜV Rheinland LGA Products GmbH
nal von minden GmbH
Importer
🇩🇪 Germany·1 Manufacturer