510(k) Report

FDA applicant

Midwest Rf, LLC

Hartland, WI9 decisions2000–20110 recalls

FDA records 9 decisions for Midwest Rf, LLC (Hartland, WI) from 2000 to 2011: 9 510(k) clearances. Most are in product codes MOS (Coil, Magnetic Resonance, Specialty) and OAP (Laser, Comb, Hair). 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, last Nov 3, 2026

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

How often FDA has decided Midwest Rf, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2009: 12010: 12011: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Midwest”

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