FDA applicant
Kut-Guard, Inc.
FDA records 2 decisions for Kut-Guard, Inc. (Hollywood, FL) in 1989: 2 510(k) clearances. Most are in product codes FYH (Splint, Extremity, Noninflatable, External…) and KGX (Tape And Bandage, Adhesive). 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 Kut-Guard, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Kut-Guard, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Kut-Guard, Inc.’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