Light, Surgical Headlight

What Is FDA Product Code EBA?

Light, Surgical Headlight is FDA product code EBA, Class 1, 21 CFR 872.4630.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 5 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Labeling design (4) and Labeling mix-ups (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.