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Shenzhen Urion Technology Co., Ltd. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)510(k)May 14, 2026Cardiovascular
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)510(k)Mar 26, 2026Cardiovascular
Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)510(k)Apr 25, 2025Physical Medicine
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))510(k)Feb 21, 2025Cardiovascular
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)510(k)Oct 24, 2024Cardiovascular

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