12 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
FDA Enforcement
Class II
·Terminated·Philips Healthcare Informatics, Inc.·August 27, 2014
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.
FDA Enforcement
Class II
·Completed·Bio-Rad Labs·May 6, 2020
CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15,
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·March 22, 2017
Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone.
FDA Enforcement
Class II
·Terminated·G & H Wire Company·March 10, 2021
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
FDA Enforcement
Class II
·Ongoing·DePuy Orthopaedics, Inc.·March 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
FDA Enforcement
Class II
·Ongoing·DePuy Orthopaedics, Inc.·March 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
FDA Enforcement
Class II
·Ongoing·DePuy Orthopaedics, Inc.·March 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
FDA Enforcement
Class II
·Ongoing·DePuy Orthopaedics, Inc.·March 29, 2023
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
FDA Enforcement
Class II
·Ongoing·DePuy Orthopaedics, Inc.·March 29, 2023
Horizon Cardiology Hemo. Version 12.2.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024