BEUDAMED
    70 results · 21ms · Sources: EU EUDAMED, US FDA

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     SAF (self-adjusting file) 

    Device
    EU MDR · Eu Md Class 2a ·ReDent Nova GmbH·On the market·1 country

     SAF (self-adjusting file)

    Device
    EU MDR · Eu Md Class 2a ·ReDent Nova GmbH·On the market·1 country

    ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE

    Device
    EU MDR · Eu Md Class 1 ·Funke Medical GmbH·On the market·5 countries

    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

    SAF (Self-adjusting file)

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·ReDent Nova GmbH·2 devices

    Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

    FDA Enforcement
    Class II ·Terminated·Voco GmbH·October 9, 2019

    Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·August 6, 2014

    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

    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

    SP Filling

    Manufacturer
    🇩🇪 Germany·1 Basic UDI-DI·16 Devices

    EUKITT

    Device
    EU IVDR · Eu Ivd Class A ·SP Filling·On the market·22 countries

    EUKITT eco classic

    Device
    EU IVDR · Eu Ivd Class A ·SP Filling·On the market·22 countries

    EUKITT eco classic

    Device
    EU IVDR · Eu Ivd Class A ·SP Filling·On the market·22 countries

    EUKITT eco

    Device
    EU IVDR · Eu Ivd Class A ·SP Filling·On the market·22 countries

    EUKITT eco

    Device
    EU IVDR · Eu Ivd Class A ·SP Filling·On the market·21 countries

    EUKITT neo spezial

    Device
    EU IVDR · Eu Ivd Class A ·SP Filling·On the market·22 countries

    EUKITT neo spezial

    Device
    EU IVDR · Eu Ivd Class A ·SP Filling·On the market·22 countries

    EUKITT neo spezial

    Device
    EU IVDR · Eu Ivd Class A ·SP Filling·On the market·22 countries

    EUKITT neo

    Device
    EU IVDR · Eu Ivd Class A ·SP Filling·On the market·21 countries

    EUKITT classic

    Device
    EU IVDR · Eu Ivd Class A ·SP Filling·On the market·22 countries