Suzhou Leapmed Healthcare Corporation FDA Approvals

0 new drug approvals and 4 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	What it is	Route	Decided
Disposable Coaxial Biopsy Needle510(k)Jul 6, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 6, 2022
Disposable Semi Automatic Biopsy Instrument510(k)Jul 6, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 6, 2022
Disposable Biopsy Refill Needle510(k)Jul 6, 2022Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Jul 6, 2022
Disposable Automatic Core Biopsy Instrument510(k)Nov 10, 2021Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Nov 10, 2021