FDA applicant
Carl Zeiss Suzhou Co., Ltd.
FDA records 2 decisions for Carl Zeiss Suzhou Co., Ltd. (Suzhou, CN) from 2017 to 2018: 2 510(k) clearances. Most are in product codes NBL (Light-Induced Fluorescence Caries Detector) and OBO (Tomography, Optical Coherence). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Suzhou Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Carl Zeiss Suzhou Co., Ltd.’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.