FDA applicant

Myco Medical, Inc.

Cary, NC2 decisions2002–20170 recalls

FDA records 2 decisions for Myco Medical, Inc. (Cary, NC) from 2002 to 2017: 2 510(k) clearances. Most are in product codes BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) and NEW (Suture, Surgical, Absorbable, Polydioxanone). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Myco Medical”.

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

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

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

FDA decisions per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Myco Medical, 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

Other applicant names beginning “Myco”

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

Myco Medical Supplies, Inc. 12

Myco Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Myco”