FDA applicant

Spectrum/Hydro-Med Products, Inc.

Dallas, TX1 decision1988–19880 recalls

FDA records 1 decision for Spectrum/Hydro-Med Products, Inc. (Dallas, TX) in 1988: 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 Spectrum/Hydro-Med Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spectrum/Hydro-Med Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Spectrum/Hydro-Med 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 “Spectrum/Hydro-Med”

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

Spectrum Medical, Ltd. 23 Spectrum Designs, Inc. 18 Spectrum X-Ray Corp. 9 Spectrum Dynamics Medical, Ltd. 8 Spectrum Spine, LLC 8 Spectrum Vascular 6 Spectrum Co. 3 Spectrum Medical Technologies, Inc. 3 Spectrum Diagnostic, Inc. 3 Spectrum Dynamics, Ltd. 3 Spectrum Antimicrobials, Inc. 1 Spectrum Antimicrobials, Inc. (Subsidiary of… 1

Spectrum/Hydro-Med Products, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Spectrum/Hydro-Med”