DeviceClearance

Product code HNR— Ophthalmic

MANUAL OPHTHALMIC SURGICAL INSTRUMENTS

Classification name
Forceps, Ophthalmic
Device class
Class 1
Regulation
21 CFR 886.4350
Advisory panel
Ophthalmic
Total cleared
44
First cleared
Most recent

Market context for product code HNR

FDA has cleared 44 devices under product code HNR between 1976 and 2002, filed by 26 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

Top applicants under product code HNR

Adverse events under product code HNR

product code HNR
Malfunction
497
Other
1
Total
498

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 HNR

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