The approval number for its FDA clearance is K052396 and Model 615 is cleared for over the counter sale without the need for a prescription.

In 2005 a Canadian company called TSO3 Inc received FDA clearance to sell an ozone sterilizer for use in healthcare.

"We're waiting for FDA clearance."

Since August 2001, the CyberKnife system has FDA clearance for treatment of tumors in any location of the body.

FDA clearance is for lower risk devices that are shown to be as safe and effective as a similar device already on the market.

(Ruby does not need FDA clearance because it is based on products that occur naturally.)

MammaPrint has 5 FDA clearances and is the only FDA cleared microarray assay available.

Although the products on the list have received FDA clearance, all products may not be currently available on the market.

Manufacturers who prove both safety and efficacy may enter the market, with FDA clearance, utilizing the 510(k) process instead of the premarket approval process, at this time.

Although cell phones can be sold without FDA clearance or approval, the agency monitors the effects the phones have on health.