510(k) Report

FDA applicant

Alliqua Biomedical, Inc.

Eden Prairie, MN2 decisions2016–20170 recalls

FDA records 2 decisions for Alliqua Biomedical, Inc. (Eden Prairie, MN) from 2016 to 2017: 2 510(k) clearances. Most are in product codes NRB (Wound Cleaner, Ultrasound) and FRO (Dressing, Wound, Drug). 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, general and plastic surgery panel, where it files most

How often FDA has decided Alliqua Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2016: 12017: 1
2016high 1 (2016) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Alliqua Biomedical, Inc. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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