FDA applicant
Tissue Regeneration Technologies, LLC
FDA records 5 decisions for Tissue Regeneration Technologies, LLC (Woodstock, GA) from 2006 to 2021: 5 510(k) clearances. Most are in product codes ISA (Massager, Therapeutic, Electric) and PZL (Extracorporeal Shock Wave Device For Treatment…). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Tissue Regeneration Technologies”, “Tissue Regeneration Technologies, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tissue Regeneration Technologies, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Tissue Regeneration Technologies, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Tissue”
FDA records each applicant name separately; these may or may not be the same firm.