FDA applicant
Formatk Systems, Ltd.
FDA records 4 decisions for Formatk Systems, Ltd. (Tirat Carmel, IL) from 2016 to 2018: 4 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONF (Powered Light Based Non-Laser Surgical…). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 101 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Formatk Systems, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Formatk Systems, Ltd.’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