510(k) Report

FDA applicant

Kut-Guard, Inc.

Hollywood, FL2 decisions1989–19890 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

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.

FIG. 1 — Kut-Guard, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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