2,082 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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Argon Medical Production & Vertriebs Gesellschaft mbH & Co. KG
Manufacturer
🇩🇪 Germany·855 Basic UDI-DIs·855 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.
Medprin Biotech GmbH
Manufacturer
🇩🇪 Germany·155 Basic UDI-DIs·154 Devices·BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., BSI Group The Netherlands B.V., and BSI Group The Netherlands B.V.
NovaCutis GmbH
Manufacturer
🇩🇪 Germany·4 Basic UDI-DIs·4 Devices·BSI Group The Netherlands B.V. and BSI Group The Netherlands B.V.
IBL International GmbH
Manufacturer
🇩🇪 Germany·23 Basic UDI-DIs·29 Devices·BSI Group The Netherlands B.V.
RECIPE Chemicals + Instruments GmbH
Manufacturer
🇩🇪 Germany·74 Basic UDI-DIs·97 Devices·BSI Group The Netherlands B.V.
exocad GmbH
Manufacturer
🇩🇪 Germany·8 Basic UDI-DIs·12 Devices·BSI Group The Netherlands B.V.
orangedental GmbH & Co. KG
Manufacturer
🇩🇪 Germany·6 Basic UDI-DIs·7 Devices·BSI Group The Netherlands B.V.
Dr. Kleine Pharma GmbH
Manufacturer
🇩🇪 Germany·16 Basic UDI-DIs·17 Devices·DQS Medizinprodukte GmbH, DQS Medizinprodukte GmbH, and BSI Group The Netherlands B.V.
FBI Medizintechnik GmbH
Importer
🇩🇪 Germany·1 Manufacturer
FBI Medizintechnik GmbH
Authorized representative
🇩🇪 Germany·1 Manufacturer
aricona GmbH
Importer
🇩🇪 Germany·3 Manufacturers
Freyr Life Sciences GmbH
Authorized representative
🇩🇪 Germany·18 Manufacturers·10 Devices
PureMDR GmbH
Authorized representative
🇩🇪 Germany·9 Manufacturers·21 Devices
44232121827
Certificate
MDD Annex II (excluding section 4)·Si-tec GmbH Dental-Spezialartikel·TÜV NORD CERT GmbH·6 Basic UDI-DIs
RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.
FDA Enforcement
Class II
·Terminated·Brainlab AG·May 1, 2019
StypCel
Device
EU MDD
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Eu Md Class 3
·Medprin Biotech GmbH·On the market·1 country
StypCel
Device
EU MDD
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Eu Md Class 3
·Medprin Biotech GmbH·On the market·1 country
StypCel
Device
EU MDD
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Eu Md Class 3
·Medprin Biotech GmbH·On the market·1 country
StypCel
Device
EU MDD
·
Eu Md Class 3
·Medprin Biotech GmbH·On the market·1 country
StypCel
Device
EU MDD
·
Eu Md Class 3
·Medprin Biotech GmbH·On the market·1 country