510(k) Report

FDA applicant

Surgical Dynamics, Inc.

Alameda, CA12 decisions1989–19960 recalls

FDA records 12 decisions for Surgical Dynamics, Inc. (Alameda, CA) from 1989 to 1996: 12 510(k) clearances. Most are in product codes HRX (Arthroscope) and GET (Motor, Surgical Instrument, Pneumatic Powered). 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, orthopedic panel, where it files most

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

FDA decisions per year

No FDA decision for Surgical Dynamics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Surgical Dynamics, 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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