K030401

Substantially Equivalent

DISPOSABLE M2-PE MICROKERATOME BLADES

Applicant: Oasis Medical, Inc.
Product code: HNO
Advisory panel: Ophthalmic
Date received: 2003-02-06
Decision date: 2003-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, CA, US

Adverse events under product code HNO

product code HNO

Injury: 390
Total: 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.