FDA applicant
Hadleigh Health Technologies
FDA records 3 decisions for Hadleigh Health Technologies (San Rafael, CA) from 2018 to 2025: 3 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and HEX (Colposcope (And Colpomicroscope)). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Hadleigh Health Technologies, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hadleigh Health Technologies’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Hadleigh Health Technologies’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) Report