510(k) Report

FDA applicant

Camtronics, Ltd.

Hartland, WI16 decisions1987–20023 recalls

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, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

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

2008: 2
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Camtronics, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Camtronics”

FDA records each applicant name separately; these may or may not be the same firm.