Medical Device Manufacturer · KR , Anseong-Si

Shina Med Corporation - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2016

Recent clearances: Sure-Fine Insulin Syringes, SureFine Pen Needle, Shina Syringe

7
Total
7
Cleared
0
Denied

FDA 510(k) Regulatory Record - Shina Med Corporation General Hospital ✕

7 devices
1-7 of 7
Cleared Oct 15, 2025
Sure-Fine Insulin Syringes
K250510 · FMF
General Hospital · 236d
Cleared Apr 03, 2025
SureFine Pen Needle
K250658 · FMI
General Hospital · 29d
Cleared Oct 27, 2023
Shina Syringe
K231165 · MEG
General Hospital · 185d
Cleared Mar 01, 2022
Sure-Fine Insulin Syringes
K210848 · FMF
General Hospital · 344d
Cleared Sep 06, 2019
Sure-Fine Insulin Syringes
K191531 · FMF
General Hospital · 88d
Cleared Sep 09, 2016
Sure-Fine Insulin Syringes
K152879 · FMF
General Hospital · 345d
Cleared Jun 07, 2016
SureFine Pen Needle
K152877 · FMI
General Hospital · 251d
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