FDA applicant

Specialty Systems, Inc.

Western, FL1 decision1997–19970 recalls

FDA records 1 decision for Specialty Systems, Inc. (Western, FL) in 1997: 1 510(k) clearance. All are in product code MDA (Elastomer, Silicone, For Scar Management). 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 Specialty Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Specialty Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Specialty 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 “Specialty”

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

Specialty Surgical Products, Inc. 13 Specialty Ultravision, Inc. 12 Specialty Packaging Producs, Inc. 11 Specialty Medical Products Co. 4 Specialty Appliance Works, Inc. 3 Specialty Medical Industries, Inc. 3 Specialty Water Technologies 2 Specialty Spine Products, LLC 2 Specialty Fibres and Materials, Ltd. 2 Specialty Health Products, Inc. 2 Specialty Dialysis Services 1 Specialty Drives Technologies, Inc. 1

Specialty 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 “Specialty”