FDA applicant

Rodenstock USA Inc.,

Danbury, CT1 decision1994–19940 recalls

FDA records 1 decision for Rodenstock USA Inc., (Danbury, CT) in 1994: 1 510(k) clearance. All are in product code HQY (Sunglasses (Non-Prescription Including…). 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 Rodenstock USA Inc.,’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rodenstock USA Inc., since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Rodenstock”

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

Rodenstock Instrument Corp. 2

Rodenstock USA Inc.,

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Rodenstock”