510(k) Report

FDA applicant

Falcon Medical Industries, Inc.

Delano, FL1 decision1987–19870 recalls

FDA records 1 decision for Falcon Medical Industries, Inc. (Delano, FL) in 1987: 1 510(k) clearance. All are in product code FMK (Single Use Only Blood Lancet With An Integral…). 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 Falcon Medical Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Falcon Medical Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Falcon Medical Industries, 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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Other applicant names beginning “Falcon”

FDA records each applicant name separately; these may or may not be the same firm.