FDA applicant

Alpine Biomed Aps

Skovlunde, DK1 decision2014–20140 recalls

FDA records 1 decision for Alpine Biomed Aps (Skovlunde, DK) in 2014: 1 510(k) clearance. All are in product code GZL (Electrode, Depth). 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, neurology panel, where it files most

How often FDA has decided Alpine Biomed Aps’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Alpine Biomed Aps by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Alpine Biomed Aps’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 “Alpine”

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

Alpine Dental Equipment Co. 10 Alpine Specialties, Inc. 2 Alpine Oral Care, LLC 1

Alpine Biomed Aps

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Alpine”