FDA applicant
Carl Zeiss Surgical GmbH
FDA records 4 decisions for Carl Zeiss Surgical GmbH (North Attleboro, MA) from 2005 to 2012: 4 510(k) clearances. Most are in product codes JAD (System, Therapeutic, X-Ray) and IZI (System, X-Ray, Angiographic). Its devices cite 13 predicates, 1 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Carl Zeiss Surgical GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Carl Zeiss Surgical 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.