FDA applicant

Allwin Medical Devices, Inc.

Anaheim, CA8 decisions2019–20260 recalls

FDA records 8 decisions for Allwin Medical Devices, Inc. (Anaheim, CA) from 2019 to 2026: 8 510(k) clearances. Most are in product codes MQF (Catheter, Assisted Reproduction) and MQK (Labware, Assisted Reproduction). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Allwin Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019high 3 (2019) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Allwin Medical Devices, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Allwin Medical Devices, Inc.

Which product codes does it file in?

What has FDA decided for it lately?