FDA applicant
Carl Zeiss Jena GmbH
FDA records 1 decision for Carl Zeiss Jena GmbH (Washington, DC) in 2001: 1 510(k) clearance. All are in product code HKI (Camera, Ophthalmic, Ac-Powered). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Carl Zeiss Jena GmbH’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Carl Zeiss Jena GmbH since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Carl Zeiss Jena 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 “Carl”
FDA records each applicant name separately; these may or may not be the same firm.