FDA applicant
Galil Medical, Ltd.
FDA records 31 decisions for Galil Medical, Ltd. (Washington, DC) from 1998 to 2020: 31 510(k) clearances. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and NEY (System, Ablation, Microwave And Accessories). Since 2016 its 510(k)s took a median of 28 days from receipt to decision, against 72 for FDA’s reviews in the same codes and years. Its devices cite 51 predicates, 48 of them its own earlier devices. 53 recalls are linked to its devices.
FDA’s records also spell it “Galil Medical, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Galil Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
46in 2020
Class I Class II/III not classified
Planning a device like Galil Medical, 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