DeviceClearance

Product code HNO— Ophthalmic

BARRAQUER-KRUMEICH REFRACTIVE SET

Classification name
Keratome, Ac-Powered
Device class
Class 1
Regulation
21 CFR 886.4370
Advisory panel
Ophthalmic
Total cleared
83
First cleared
Most recent

Market context for product code HNO

FDA has cleared 83 devices under product code HNO between 1976 and 2018, filed by 40 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code HNO

Adverse events under product code HNO

product code HNO
Injury
390
Total
390

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code HNO

Data sourced from openFDA. This site is unofficial and independent of the FDA.