Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer— 510(k) K163337

Substantially Equivalent

Midmark Corporation

FDA 510(k) clearance K163337 for Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer, Substantially Equivalent on 2017-08-31. Applicant: Midmark Corporation.

Clearance details

Applicant: Midmark Corporation
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2016-11-28
Decision date: 2017-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Versailles, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.