FDA applicant

WAVE Medical AG

Neuhausen Am Rheinfall, CH1 decision2026–20260 recalls

FDA records 1 decision for WAVE Medical AG (Neuhausen Am Rheinfall, CH) in 2026: 1 510(k) clearance. All are in product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). 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, cardiovascular panel, where it files most

How often FDA has decided WAVE Medical AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

Planning a device like WAVE Medical AG’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”

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-Form Systems, Inc. 1 Wave Neuroscience 1

WAVE Medical AG

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “WAVE”