3 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
FDA Enforcement
Class II
·Terminated·LumiraDx·July 27, 2022
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
FDA Enforcement
Class II
·Ongoing·Microbiologics Inc·April 2, 2025
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
FDA Enforcement
Class II
·Terminated·RAYSEARCH LABORATORIES AB·June 3, 2015