510(k) Report

FDA applicant

Storz

St. Louis, MO6 decisions1992–19965 recalls

FDA records 6 decisions for Storz (St. Louis, MO) from 1992 to 1996: 6 510(k) clearances. Most are in product codes HQC (Unit, Phacofragmentation) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 1 predicate, 0 of them its own earlier devices. 5 recalls are 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 Storz’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Storz since 2007.

Recalls per year

4in 2010

2010: 4
2007high 4 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Storz”

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