FDA applicant

Carl Zeiss Ophthalmic Systems, Inc.

Dublin, CA2 decisions2002–20020 recalls

FDA records 2 decisions for Carl Zeiss Ophthalmic Systems, Inc. (Dublin, CA) in 2002: 2 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and NFF (Device, Storage, Images, Ophthalmic). Its devices cite 1 predicate, 0 of them its own earlier devices. 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, radiology panel, where it files most

How often FDA has decided Carl Zeiss Ophthalmic Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Carl Zeiss Ophthalmic Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Carl”

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

Carl Zeiss Meditec, AG 81 Carl Zeiss, Inc. 44 Carl Zeiss Meditec Cataract Technology, Inc. 7 Carl Parker Associates, Inc. 7 Carl Zeiss Surgical GmbH 4 Carl Zeiss Suzhou Co., Ltd. 2 Carl Zeiss Jena GmbH 1 Carl Zeiss Vision GmbH 1 Carl Schuh 1 Carl Zeiss Meditec Production, LLC 1 Carl Zeiss Meditec Cataract Technologies 1

Carl Zeiss Ophthalmic Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Carl”