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2023 Mid-Year Report on FDA 510(K) Clearances

Focusing on clearance times, and changes over the last decade.


Gain up-to-date insights for your data-driven decisions & go-to-market planning

  • Clearance time by submission type: Traditional 510(K), Special 510(K), De Novo, and more

  • Clearance time by medical specialty

  • Devices cleared in 2023 by 510(K) submission type and by medical specialty

  • Comparisons to past decade

  • Global overview

  • And more...

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