FDA applicant

Stereotactic Medical Systems, Inc.

New Harford, NY5 decisions1986–19890 recalls

FDA records 5 decisions for Stereotactic Medical Systems, Inc. (New Harford, NY) from 1986 to 1989: 5 510(k) clearances. Most are in product codes HAW (Neurological Stereotaxic Instrument) and FRN (Pump, Infusion). 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, neurology panel, where it files most

How often FDA has decided Stereotactic Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Stereotactic Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Stereotactic Medical Systems, 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 “Stereotactic”

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

Stereotactic Image Systems, Inc. 1

Stereotactic Medical Systems, 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?

Other applicant names beginning “Stereotactic”