510(k) Report

FDA applicant

ZEISS

Mchenry, IL2 decisions1982–19820 recalls

FDA records 2 decisions for ZEISS (Mchenry, IL) in 1982: 2 510(k) clearances. Most are in product codes HQG (Lens, Spectacle, Non-Custom (Prescription)) and GEI (Electrosurgical, Cutting & Coagulation &…). 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 ZEISS’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for ZEISS since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like ZEISS’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 “ZEISS”

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