Understanding the difference between FDA-cleared and FDA-approved medical devices is essential for manufacturers, startups, and regulatory teams entering the US healthcare market. These two terms reflect distinct regulatory pathways, review depths, and risk levels under US FDA oversight. This article explains how clearance and approval differ, when each applies, and why the distinction matters for compliance, product positioning, and market entry decisions. It also clarifies common misconceptions that often lead to regulatory confusion. By understanding FDA cleared vs FDA approved, companies can communicate accurately, reduce regulatory risk, and align expectations across teams involved in development and commercialization.