FDA applicant

Leica Microsystems, Inc.

Depew, NY2 decisions1999–20060 recalls

FDA records 2 decisions for Leica Microsystems, Inc. (Depew, NY) from 1999 to 2006: 2 510(k) clearances. Most are in product codes HKX (Tonometer, Ac-Powered) and IZI (System, X-Ray, Angiographic). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Leica Microsystems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Leica Microsystems, 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 “Leica”

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

Leica Biosystems Newcastle, Ltd. 6 Leica Biosystems Imaging, Inc. 5 Leica Microsystems (Schweiz) AG 4 Leica, Inc. 3 Leica Biosystems 1 Leica Microsystems, Inc. O.I.D. 1 Leica Microscopy Systems, Ltd. 1 Leica Biosystems Richmond 1

Leica Microsystems, 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 “Leica”