FDA applicant

Myelotec, Inc.

Mt. Airy, MD3 decisions1996–20133 recalls

FDA records 3 decisions for Myelotec, Inc. (Mt. Airy, MD) from 1996 to 2013: 3 510(k) clearances. All are in product code HRX (Arthroscope). Its devices cite 3 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Myelotec”.

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 Myelotec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Myelotec, Inc.’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

Myelotec, Inc.

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?