Hantech Medical Device 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	What it is	Route	Decided
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)510(k)Sep 27, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Sep 27, 2023
Disposable Insulin Pen Needle510(k)Apr 6, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Apr 6, 2023
Disposable Insulin Syringe510(k)Mar 6, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Mar 6, 2023
Disposable Medical Masks510(k)Sep 1, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 1, 2022
Disposable Medical Safety Hypodermic Needle510(k)Aug 23, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Aug 23, 2022