510(k) Report

FDA applicant

Noetix, Inc.

Indianapolis, IN3 decisions1987–19890 recalls

FDA records 3 decisions for Noetix, Inc. (Indianapolis, IN) from 1987 to 1989: 3 510(k) clearances. Most are in product codes HNY (Cystotome) and HQC (Unit, Phacofragmentation). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Noetix, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Noetix, 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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