FDA applicant
Heidelberg Engineering GmbH
FDA records 27 decisions for Heidelberg Engineering GmbH (Heidelberg, DE) from 1991 to 2026: 27 510(k) clearances. Most are in product codes OBO (Tomography, Optical Coherence) and HLI (Ophthalmoscope, Ac-Powered). Since 2016 its 510(k)s took a median of 163 days from receipt to decision, against 141 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 20 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Heidelberg Engineering”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Heidelberg Engineering GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Heidelberg Engineering GmbH’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) ReportOther applicant names beginning “Heidelberg”
FDA records each applicant name separately; these may or may not be the same firm.