Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Tissium with 8 device recalls and 1 510(k) clearance. The most recent is a device recall dated Jun 15, 2026: Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOC….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: IClass II · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect r | Device recalls |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: IClass II · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect r | Device recalls |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: IClass II · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect r | Device recalls |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: IClass II · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect r | Device recalls |
| Jun 15, 2026 | Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: IClass II · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect r | Device recalls |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: IClass II · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect r | Device recalls |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: IClass II · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect r | Device recalls |
| Jun 15, 2026 | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: IClass II · Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect r | Device recalls |
| Sep 8, 2025 | Coaptium Connect with Tissium LightK251957 · SFD | 510(k) clearances |
| Jun 17, 2025 | COAPTIUM Connect with TISSIUM LIGHTDEN240066 · SFD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
