It is sometimes hard to rember the difference between FDA cleared vs FDA approved medications and devices. I googled this and found some explations of what the difference is: Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device that has been officially approved already. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer.
See the following link:
https://www.fda.gov/aboutfda/transparency/basics/ucm194468.htm