FDA applicant

Wave-Form Systems, Inc.

Portland, OR1 decision1990–19900 recalls

FDA records 1 decision for Wave-Form Systems, Inc. (Portland, OR) in 1990: 1 510(k) clearance. All are in product code KKX (Drape, Surgical, Antimicrobial). 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 Wave-Form Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wave-Form Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Wave-Form Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Wave-Form”

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

Wave Energy Systems, Inc. 1 Wave Form Mfg., Inc. 1 WAVE Medical AG 1 Wave Neuroscience 1

Wave-Form Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Wave-Form”