FDA applicant

Romano Surgical Instrumentation, Inc.

Seattle, WA2 decisions1988–19890 recalls

FDA records 2 decisions for Romano Surgical Instrumentation, Inc. (Seattle, WA) from 1988 to 1989: 2 510(k) clearances. All are in product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic…). 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 Romano Surgical Instrumentation, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Romano Surgical Instrumentation, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Romano Surgical Instrumentation, 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

Romano Surgical Instrumentation, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?