510(k) Report

FDA applicant

Andwin Scientific

Woodland Hills, CA3 decisions1997–19980 recalls

FDA records 3 decisions for Andwin Scientific (Woodland Hills, CA) from 1997 to 1998: 3 510(k) clearances. Most are in product codes HHT (Spatula, Cervical, Cytological) and JKA (Tubes, Vials, Systems, Serum Separators, Blood…). 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 Andwin Scientific’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Andwin Scientific since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Andwin Scientific by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Andwin Scientific’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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