510(k) Report

FDA applicant

Howard Instruments, Inc.

Tuscaloosa, AL5 decisions1997–20070 recalls

FDA records 5 decisions for Howard Instruments, Inc. (Tuscaloosa, AL) from 1997 to 2007: 5 510(k) clearances. Most are in product codes HNO (Keratome, Ac-Powered) and GEX (Powered Laser Surgical Instrument). 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, ophthalmic panel, where it files most

How often FDA has decided Howard Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Howard”

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