Torax Medical, Inc.

FDA Regulatory Profile

Torax Medical, Inc. appears in FDA public data with 5 recalls, 2 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2041-2018, Class II) was initiated on April 20, 2018. Its most recent 510(k) clearance was granted on February 9, 2023.

Summary

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

Recent Recalls

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