FDA applicant

Leica Microsystems (Schweiz) AG

Heerbrugg, CH4 decisions2008–20190 recalls

FDA records 4 decisions for Leica Microsystems (Schweiz) AG (Heerbrugg, CH) from 2008 to 2019: 3 510(k) clearances and 1 De Novo grant. Most are in product codes IZI (System, X-Ray, Angiographic) and QFX (Diagnostic Neurosurgical Microscope Filter). Its devices cite 7 predicates, 1 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 Leica Microsystems (Schweiz) AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Leica Microsystems (Schweiz) AG by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Leica Microsystems (Schweiz) AG’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 “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, Inc. 3 Leica Microsystems, Inc. 2 Leica Biosystems 1 Leica Microsystems, Inc. O.I.D. 1 Leica Microscopy Systems, Ltd. 1 Leica Biosystems Richmond 1

Leica Microsystems (Schweiz) AG

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”