FDA applicant

Heidelberg Instruments

La Jolla, CA1 decision1986–19860 recalls

FDA records 1 decision for Heidelberg Instruments (La Jolla, CA) in 1986: 1 510(k) clearance. All are in product code HJB (Instrument, Measuring, Corneal Radius). 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 Heidelberg Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heidelberg Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Heidelberg”

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

Heidelberg Engineering GmbH 27 Heidelberg Medical Products 1

Heidelberg Instruments

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Heidelberg”