Kenpax International Limited 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
Protective Gown AAMI Level 4510(k)Aug 8, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Aug 8, 2023
Sterilization Wrap510(k)Mar 23, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 23, 2023
Isolation Gown AAMI Level 3510(k)Nov 7, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 7, 2021
Procedure Mask, Surgical Mask510(k)May 20, 2021General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 20, 2021