TISSIUM SA

FDA Regulatory Profile

TISSIUM SA appears in FDA public data with 8 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2903-2026, Class II) was initiated on June 15, 2026. Its most recent 510(k) clearance was granted on September 8, 2025.

Summary

Total Recalls
8
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2903-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 SoftwJune 15, 2026
Z-2906-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 SoftwJune 15, 2026
Z-2907-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 SoftwJune 15, 2026
Z-2901-2026Class IIBrand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 SoftwJune 15, 2026
Z-2904-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 SoftwJune 15, 2026
Z-2902-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 SoftwJune 15, 2026
Z-2905-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 SoftwJune 15, 2026
Z-2908-2026Class IIBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 SoftwJune 15, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K251957Coaptium Connect with Tissium LightSeptember 8, 2025
DEN240066COAPTIUM Connect with TISSIUM LIGHTJune 17, 2025