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Gemss Healthcare Co., Ltd. FDA Approvals

0 new drug approvals and 3 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
XLITE510(k)Aug 3, 2026Radiology
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)510(k)Nov 16, 2023Radiology
XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50510(k)Nov 2, 2023Radiology

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