Speed, Speed Shift, Speed Titan, Speed Arc— 510(k) K142292

Substantially Equivalent

Biomedical Enterprises, Inc.

FDA 510(k) clearance K142292 for Speed, Speed Shift, Speed Titan, Speed Arc, Substantially Equivalent on 2014-11-17. Applicant: Biomedical Enterprises, Inc..

Clearance details

Applicant: Biomedical Enterprises, Inc.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2014-08-18
Decision date: 2014-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.