6 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
FDA Enforcement
Class II
·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
FDA Enforcement
Class II
·Ongoing·LEONI CIA CABLE SYSTEMS·November 29, 2023
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
FDA Enforcement
Class II
·Ongoing·Cypress Medical Products LLC·September 25, 2024
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
FDA Enforcement
Class II
·Ongoing·Abbott Diagnostics Technologies AS·September 4, 2024
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
FDA Enforcement
Class II
·Ongoing·Cypress Medical Products LLC·September 25, 2024
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 27, 2025