SINMED POSITIONING DEVICES— 510(k) K060737

Substantially Equivalent

Sinmed BV

FDA 510(k) clearance K060737 for SINMED POSITIONING DEVICES, Substantially Equivalent on 2006-03-31. Applicant: Sinmed BV.

Clearance details

Applicant: Sinmed BV
Product code: Code IYE
Advisory panel: Radiology
Date received: 2006-03-20
Decision date: 2006-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reeuwijk, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.