12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Germany
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DTB Gesellschaft für digitale Therapiebegleitung mbH
Manufacturer
🇩🇪 Germany
OrthoPreventAligner® DB-W
Device
EU MDR
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Eu Md Class 1
·Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG·On the market·1 country
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
FDA Enforcement
Class II
·Terminated·PTW-Freiburg·September 2, 2015
Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology.
FDA Enforcement
Class II
·Ongoing·PTW-FREIBURG·February 28, 2024
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module from BeamAdjust S080032, UDI-DI: EPTWS0800320 ): " OCTAVIUS Detector 1600 SRS (T10056) (UDI-DI: EPTWT100560) " OCTAVIUS Detector 1600 MR (T10057) (UDI-DI: EPTWT100570) " OCTAVIUS Detector 1600 XDR (T10058) (UDI-DI: EPTWT100580) " OCTAVIUS Detector 1000 SRS (T10036) (UDI-DI: EPTWT100360)
FDA Enforcement
Class II
·Ongoing·PTW-FREIBURG·September 20, 2023
DTS-DESIGN GmbH
Importer
🇩🇪 Germany
MTW - Endoskopie W. Haag KG
Importer
🇩🇪 Germany
DW Commerce GmbH
Authorized representative
🇩🇪 Germany
Orthana GmbH
Importer
🇩🇪 Germany·12 Manufacturers
SPIGGLE &THEIS Medizintechnik GmbH
Importer
🇩🇪 Germany·19 Manufacturers
Ortho Organizers GmbH
Importer
🇩🇪 Germany·34 Manufacturers
Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
🇩🇪 Germany·637 Manufacturers·33064 Devices