FDA-cleared and FDA-approved are commonly misunderstood terms in the medical device industry, yet the difference has important regulatory and business implications. This article provides a clear, non-technical explanation of how the US FDA reviews medical devices based on risk, intended use, and supporting evidence. It highlights common misconceptions, explains when each designation applies, and outlines why accurate terminology matters for labeling, marketing, and regulatory compliance. If you are involved in device development or regulatory strategy, this overview of FDA cleared vs FDA approved medical devices offers valuable clarity.