FDA applicant

Sterile Medical Systems

South Weymouth, MA1 decision1984–19840 recalls

FDA records 1 decision for Sterile Medical Systems (South Weymouth, MA) in 1984: 1 510(k) clearance. All are in product code GAX (Tourniquet, Nonpneumatic). 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 Sterile Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sterile Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Sterile”

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

Sterile Concepts, Inc. 10 Sterile Design, Inc. 10 Sterile Containment Technology, LLC 1

Sterile Medical Systems

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sterile”