Medical Device Manufacturer · CN , Hangzhou

Promisemed Hangzhou Meditech Co., Ltd. - FDA 510(k) Cleared Devices

32 submissions · 32 cleared · Since 2017
32
Total
32
Cleared
0
Denied

FDA 510(k) cleared devices by Promisemed Hangzhou Meditech Co., Ltd. General Hospital

23 devices
1-23 of 23
Cleared Dec 10, 2025
Verisafe Safety Retractable Insulin Syringes
K250192 · FMF
General Hospital · 321d
Cleared Jun 04, 2025
Blood collection tube holders
K250961 · JKA
General Hospital · 65d
Cleared May 13, 2025
Promisemed Safety Huber Needles
K251138 · PTI
General Hospital · 29d
Cleared Mar 14, 2025
Promisemed Safety Huber Needles
K243332 · PTI
General Hospital · 141d
Cleared Jan 10, 2025
Safety Winged Blood Collection Sets
K243806 · FMI
General Hospital · 30d
Cleared Sep 26, 2024
Verifine® Pen Needles
K242632 · FMI
General Hospital · 23d
Cleared Sep 28, 2023
VeriSafe Safety sterile syringes
K231792 · FMF
General Hospital · 100d
Cleared Jun 08, 2023
Promisemed Safety Huber Needle
K230715 · PTI
General Hospital · 85d
Cleared Mar 02, 2023
Insulin Syringe
K223453 · FMF
General Hospital · 106d
Cleared Feb 15, 2023
Verisafe Safety sterile needles
K222271 · FMI
General Hospital · 201d
Cleared Sep 19, 2022
Promisemed X-Safety Pen Needle
K220129 · FMI
General Hospital · 244d
Cleared Apr 05, 2022
Verifine Safety Syringe with Fixed Needle
K213560 · FMF
General Hospital · 147d
Cleared Nov 17, 2021
Promisemed Sharps container
K211890 · MMK
General Hospital · 149d
Cleared Sep 09, 2021
Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
K211242 · FMF
General Hospital · 136d
Cleared Sep 08, 2021
Verifine Mechanical Safety Insulin Syringe
K210712 · FMF
General Hospital · 182d
Cleared Jul 21, 2021
Promisemed Insulin Pen Needle
K210059 · FMI
General Hospital · 191d
Cleared Jun 25, 2021
Safety Winged Blood Collection Sets
K211293 · FMI
General Hospital · 60d
Cleared Apr 22, 2021
Verifine Safety Type Insulin Pen Needle
K210065 · FMI
General Hospital · 101d
Cleared Jan 05, 2021
Insulin Syringe
K193273 · FMF
General Hospital · 406d
Cleared Dec 31, 2020
Promisemed Covered Safety Pen Needle
K202681 · FMI
General Hospital · 107d
Cleared Nov 24, 2020
Promisemed Triple Safety Pen Needle
K202682 · FMI
General Hospital · 70d
Cleared Sep 05, 2019
Dual-Safety Pen Needle
K191853 · FMI
General Hospital · 57d
Cleared May 11, 2017
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
K161950 · FMI
General Hospital · 300d
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