8 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·December 27, 2023
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 30, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 30, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 30, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 30, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
FDA Enforcement
Class II
·Ongoing·Abbott Laboratories·April 30, 2025
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
FDA Enforcement
Class I
·Ongoing·GE Healthcare Finland Oy·July 12, 2023
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
FDA Enforcement
Class I
·Ongoing·SD Biosensor, Inc.·May 31, 2023