FDA applicant
Camtronics, Ltd.
FDA records 16 decisions for Camtronics, Ltd. (Hartland, WI) from 1987 to 2002: 16 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and IZI (System, X-Ray, Angiographic). Its devices cite 10 predicates, 3 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Camtronics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Camtronics, Ltd. since 2007.
Recalls per year
2in 2008
Class I Class II/III not classified
Planning a device like Camtronics, 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 “Camtronics”
FDA records each applicant name separately; these may or may not be the same firm.