FDA applicant
Carl Zeiss Meditec, AG
FDA records 81 decisions for Carl Zeiss Meditec, AG (Dublin, CA) from 1986 to 2026: 77 510(k) clearances and 4 original PMA approvals. Most are in product codes NFJ (System, Image Management, Ophthalmic) and OBO (Tomography, Optical Coherence). Since 2016 its 510(k)s took a median of 176 days from receipt to decision, against 156 for FDA’s reviews in the same codes and years. Its devices cite 139 predicates, 78 of them its own earlier devices. 17 recalls are linked to its devices.
FDA’s records also spell it “Carl Zeiss Meditec, Inc.”, “Carl Zeiss Meditec”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Carl Zeiss Meditec, AG’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Carl Zeiss Meditec, 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) ReportOther applicant names beginning “Carl”
FDA records each applicant name separately; these may or may not be the same firm.