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Torax Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
2
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2040-2018Class IILINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx onlyApril 20, 2018
Z-2041-2018Class IILINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx onlApril 20, 2018
Z-2037-2018Class IILINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx onlApril 20, 2018
Z-2039-2018Class IILINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx onApril 20, 2018
Z-2038-2018Class IILINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx onlApril 20, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K230089ETHICON LINX® Esophagus Sizing ToolFebruary 9, 2023
K201035ETHICON Linx Esophagus Sizing ToolJuly 9, 2020