137 results · 16ms · Sources: EU EUDAMED, US FDA

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LOGON OMF Bioactive Systems GmbH

Manufacturer
🇩🇪 Germany

STERILIZATION TRAY ACCESSORIES ENT/CMF

Device
EU MDR · Eu Md Class 1 ·Brainlab AG·On the market

Universal CMF System

FDA 510(k)
FDA Class 2 ·Dental

Stryker CMF MEDPOR Priority Customized Implant Kit

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)

FDA 510(k)
FDA Class 2 ·Radiology

Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY 25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER 25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER 25100-13B - PATIENT DATA MANAGER 2.5 LICENSE used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6. Product Usage: Patient Data Manager is intended to load patient data from and export patient data to connected network locations (like file shares and PACS) and removable media. Furthermore, the software is intended to start other applications (like Brainlab planning and navigation applications) and to route applications and connected video sources to displays attached to the system that are running Patient Data Manager. The software is also intended to connect two Brainlab systems to each other via network.

FDA Enforcement
Class II ·Terminated·Brainlab AG·October 30, 2019

KULZER GmbH

Manufacturer
🇩🇪 Germany·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Zrinski Solution GbR

Manufacturer
🇩🇪 Germany·1 Basic UDI-DI·1 Device·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and UDEM Adriatic d.o.o.

newbox medical GmbH

Manufacturer
🇩🇪 Germany·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

Gründler GmbH

Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY

Udo Heisig GmbH The Disposables Company

Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·5 Devices·TÜV Rheinland LGA Products GmbH

GEOMED Medizin-Technik GmbH & Co. KG

Manufacturer
🇩🇪 Germany·TÜV Rheinland LGA Products GmbH

E. HAHNENKRATT GmbH

Manufacturer
🇩🇪 Germany·TÜV Rheinland LGA Products GmbH

Gebr. Brasseler GmbH & Co. KG

Manufacturer
🇩🇪 Germany·TÜV Rheinland LGA Products GmbH

terraplasma medical GmbH

Manufacturer
🇩🇪 Germany·2 Basic UDI-DIs·8 Devices·TÜV Rheinland LGA Products GmbH

Fiagon GmbH

Manufacturer
🇩🇪 Germany·14 Basic UDI-DIs·33 Devices·SGS FIMKO OY

Löwenstein Medical Technology GmbH + Co. KG

Manufacturer
🇩🇪 Germany·TÜV Rheinland LGA Products GmbH

Carl Martin GmbH

Manufacturer
🇩🇪 Germany·1 Basic UDI-DI·1 Device·TÜV Rheinland LGA Products GmbH

Erkodent Erich Kopp GmbH

Manufacturer
🇩🇪 Germany·11 Basic UDI-DIs·43 Devices·TÜV Rheinland LGA Products GmbH

SICAT GmbH & Co. KG

Manufacturer
🇩🇪 Germany·5 Basic UDI-DIs·5 Devices·TÜV Rheinland LGA Products GmbH