FDA applicant

Specialty Health Products, Inc.

Phoenix, AZ2 decisions1989–20040 recalls

FDA records 2 decisions for Specialty Health Products, Inc. (Phoenix, AZ) from 1989 to 2004: 2 510(k) clearances. Most are in product codes KPL (Colonic Irrigation System) and FPA (Set, Administration, Intravascular). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, gastroenterology and urology panel, where it files most

How often FDA has decided Specialty Health Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Specialty Health Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Specialty Health Products, 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 Dialysis Services 1 Specialty Drives Technologies, Inc. 1 Specialty Tint 1

Specialty Health Products, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Specialty”