205 results
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7ms
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Sources: EU EUDAMED, US FDA
The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·September 11, 2019
GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2. TRAY, PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 3. TRAY, PAC II, VEN, 2.8MM, CS, 9FR/INTRO 1/EA; 4. TRAY, PAC II, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 5. TRAY, PAC II, VEN, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 6. TRAY, PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5FR/INTRO 1/EA; 7. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO, VALVED 1/EA; 8. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO, VALVED 1/EA; 9. TRAY, PAC II, VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO 1/EA; 10. TRAY, PAC II, VEN LP, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 11. TRAY, PAC II, VEN LP, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 12. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.0, PU 1/EA; 13. TRAY, PROPORT, PLASTIC, 2PC, STD, SGL LMN, 1.6, PU 1/EA; 14. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.6, PU 1/EA; 15. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, PU 1/EA; 16. TRAY, PROPORT, PLASTIC, 2PC, LP, SGL LMN, 1.0, SIL 1/EA; 17. TRAY, POWER PAC, VEN, TI, PU, 2.6MM, UL, 8.5 FR/INTRO 1/EA; 18. TRAY, POWER PAC, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 19. TRAY, POWER PAC, VEN LP, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 20. TRAY, POWER PAC II, VEN, TI, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 21. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 22. TRAY, POWER PAC II, VEN, PU, 2.6MM, PRE-AY, 8.5 FR/INTRO 1/EA; 23. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO 1/EA; 24. TRAY, POWER PAC II, VEN, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 25. TRAY, POWER PAC II, VEN LP, PU, 2.6MM, UL 8.5 FR/INTRO, VALVED 1/EA; 26. TRAY, POWER PAC II, VEN, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 27. TRAY, POWER PAC II, VEN, LP, PU, 1.9MM, UL, 6 FR/INTRO, VALVED 1/EA; 28. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 29. TRAY, POWER PAC II, VEN LP, PU, 1.9MM, PRE-AY, 6 FR/INTRO 1/EA; 30. TRAY, POWER PAC, PASPORT T2, PU, 1.9MM, UL, 6 FR/INTRO 1/EA; 31. TRAY, PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO 1/EA; 32. TRAY, POWER PAC II, DL, LP, PU, 2.2MM, WING-LOCK, 7FR, INTRO 1/EA; 33. TRAY, POWERPAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO 1/EA; 34. TRAY, POWER PAC II, DL, LP, PU, 3.2MM, WING-LOCK, 10 FR/INTRO, VALVED 1/EA;
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 30, 2019
Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an off-the-shelf PC networked with Fuji Synapse PACS.
FDA Enforcement
Class II
·Terminated·Fujifilm Medical Systems U.S.A., Inc.·June 29, 2016
REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
FDA Enforcement
Class II
·Terminated·Allergan PLC·February 10, 2021
Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F
FDA Enforcement
Class II
·Terminated·Covidien, PLC·March 27, 2019
DR Systems Unity PACS software, now known as Merge Unity PACS
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·March 15, 2017
DR Systems Unity PACS software, now known as Merge Unity PACS software.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·January 11, 2017
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others
FDA Enforcement
Class II
·Terminated·Philips Medical Systems, Inc.·April 30, 2014
DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·March 8, 2017
Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 21, 2016
Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 14, 2018
Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013
Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013
Carestream Vue PACS; Virtual Access Software, StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013
Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013
Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013
Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013
Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013
Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013
Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
FDA Enforcement
Class II
·Terminated·Carestream Health Inc.·November 20, 2013