510(k) Report

FDA applicant

Scientific Device Manufacturer, LLC

San Rafael, CA6 decisions1995–19970 recalls

FDA records 6 decisions for Scientific Device Manufacturer, LLC (San Rafael, CA) from 1995 to 1997: 6 510(k) clearances. Most are in product codes KXO (Monitor, Pressure, Intrauterine) and FOZ (Catheter, Intravascular, Therapeutic…). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Scientific Device Manufacturer, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Scientific Device Manufacturer, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Scientific Device Manufacturer, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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