HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM— 510(k) K111340

Substantially Equivalent

Medtec, Inc.

FDA 510(k) clearance K111340 for HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM, Substantially Equivalent on 2011-06-28. Applicant: Medtec, Inc..

Clearance details

Applicant: Medtec, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2011-05-12
Decision date: 2011-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange City, IA, US

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.