SPEED XL— 510(k) K133780

Substantially Equivalent

Biomedical Ent., Inc.

FDA 510(k) clearance K133780 for SPEED XL, Substantially Equivalent on 2014-03-19. Applicant: Biomedical Ent., Inc..

Clearance details

Applicant: Biomedical Ent., Inc.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2013-12-12
Decision date: 2014-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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.