Hantech Medical Device Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010), Disposable Insulin Pen Needle, Disposable Insulin Syringe
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hantech Medical Device Co., Ltd. General Hospital ✕
5 devices
Cleared
Sep 27, 2023
Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003,...
General Hospital
139d
Cleared
Apr 06, 2023
Disposable Insulin Pen Needle
General Hospital
209d
Cleared
Mar 06, 2023
Disposable Insulin Syringe
General Hospital
181d
Cleared
Sep 01, 2022
Disposable Medical Masks
General Hospital
147d
Cleared
Aug 23, 2022
Disposable Medical Safety Hypodermic Needle
General Hospital
174d