ConMed Mixing and Delivery Kit— 510(k) K142535

Substantially Equivalent

Conmed Corporation

FDA 510(k) clearance K142535 for ConMed Mixing and Delivery Kit, Substantially Equivalent on 2015-04-23. Applicant: Conmed Corporation.

Clearance details

Applicant: Conmed Corporation
Product code: Code FMF
Advisory panel: General Hospital
Date received: 2014-09-09
Decision date: 2015-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.