FDA applicant

Signal Medical Corp.

Marysville, MI11 decisions1997–20211 recall

FDA records 11 decisions for Signal Medical Corp. (Marysville, MI) from 1997 to 2021: 11 510(k) clearances. Most are in product codes MBH (Prosthesis, Knee, Patello/Femorotibial…) and JWH (Prosthesis, Knee, Patellofemorotibial…). Its devices cite 14 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Signal Medical Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

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

How often FDA has decided Signal Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Signal Medical Corp.’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) Report

Other applicant names beginning “Signal”

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

Signal West 3

Signal Medical Corp.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Signal”