510(k) K071735— MODIFICATION TO DISPOSABLE INFUSION PUMP KIT

Substantially Equivalent

Symbios Medical Products, LLC

Clearance details

Applicant: Symbios Medical Products, LLC
Product code: Code MEB
Advisory panel: General Hospital
Date received: 2007-06-26
Decision date: 2007-07-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.