DeviceClearance

Product code MRH— General Hospital

OMNI Surgical System

Classification name
Pump, Infusion, Ophthalmic
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Total cleared
20
First cleared
Most recent

Market context for product code MRH

FDA has cleared 20 devices under product code MRH between 1996 and 2026, filed by 12 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MRH

Recent clearances under product code MRH

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