FDA applicant

Instrumed International, Inc.

Schaumburg, IL7 decisions2004–20100 recalls

FDA records 7 decisions for Instrumed International, Inc. (Schaumburg, IL) from 2004 to 2010: 7 510(k) clearances. Most are in product codes DWP (Dilator, Vessel, Surgical) and GZT (Retractor, Self-Retaining, For Neurosurgery). Its devices cite 17 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, cardiovascular panel, where it files most

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

FDA decisions per year

2in 2010

2007high 2 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Instrumed International, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Instrumed”

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

Instrumed, Inc. 7

Instrumed International, 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?

Other applicant names beginning “Instrumed”