Medical Device Manufacturer · CN , Hangzhou

Promisemed Hangzhou Meditech Co., Ltd.

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

Promisemed Hangzhou Meditech Co., Ltd. — FDA 510(k) Submissions

Promisemed Hangzhou Meditech Co., Ltd. has submitted 32 FDA 510(k) premarket notifications since 2017, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Needle, Hypodermic, Single Lumen, Syringe, Piston, Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, Non-coring (huber) Needle, Instrument, Biopsy . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
Verisafe Safety Retractable Insulin Syringes
K250192 · FMF Syringe, Piston · General Hospital
Dec 2025 321d
Blood collection tube holders
K250961 · JKA Tubes, Vials, Systems,... · General Hospital
Jun 2025 65d
Promisemed Safety Huber Needles
K251138 · PTI Non-coring (huber) Needle · General Hospital
May 2025 29d
Promisemed Safety Huber Needles
K243332 · PTI Non-coring (huber) Needle · General Hospital
Mar 2025 141d
Safety Winged Blood Collection Sets
K243806 · FMI Needle, Hypodermic,... · General Hospital
Jan 2025 30d
Endoscopic Injection Needles
K240675 · FBK Endoscopic Injection... · Gastroenterology & Urology
Oct 2024 207d
Verifine? Pen Needles
K242632 · FMI Needle, Hypodermic,... · General Hospital
Sep 2024 23d
Single Use Hemoclips
K234124 · PKL Hemostatic Metal Clip For... · Gastroenterology & Urology
Jul 2024 197d
VeriSafe Safety sterile syringes
K231792 · FMF Syringe, Piston · General Hospital
Sep 2023 100d
Promisemed Safety Huber Needle
K230715 · PTI Non-coring (huber) Needle · General Hospital
Jun 2023 85d
Insulin Syringe
K223453 · FMF Syringe, Piston · General Hospital
Mar 2023 106d
Verifine? Ease Lancing Device, Verifine? Lancing Device
K223643 · QRL Multiple Use Blood Lancet... · General & Plastic Surgery
Feb 2023 77d
Verisafe Safety sterile needles
K222271 · FMI Needle, Hypodermic,... · General Hospital
Feb 2023 201d
Promisemed X-Safety Pen Needle
K220129 · FMI Needle, Hypodermic,... · General Hospital
Sep 2022 244d
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
K221368 · FMK Single Use Only Blood... · General & Plastic Surgery
Jun 2022 28d
Promisemed Heel Blood Lancet
K221371 · FMK Single Use Only Blood... · General & Plastic Surgery
Jun 2022 27d
Promisemed Fine Biopsy Needle
K213683 · KNW Instrument, Biopsy · General & Plastic Surgery
Apr 2022 151d
Verifine Safety Syringe with Fixed Needle
K213560 · FMF Syringe, Piston · General Hospital
Apr 2022 147d
Promisemed Sharps container
K211890 · MMK Container, Sharps · General Hospital
Nov 2021 149d
Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
K211242 · FMF Syringe, Piston · General Hospital
Sep 2021 136d
Verifine Mechanical Safety Insulin Syringe
K210712 · FMF Syringe, Piston · General Hospital
Sep 2021 182d
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
K210946 · KNW Instrument, Biopsy · General & Plastic Surgery
Aug 2021 135d
Promisemed Insulin Pen Needle
K210059 · FMI Needle, Hypodermic,... · General Hospital
Jul 2021 191d
Safety Winged Blood Collection Sets
K211293 · FMI Needle, Hypodermic,... · General Hospital
Jun 2021 60d
Verifine Safety Type Insulin Pen Needle
K210065 · FMI Needle, Hypodermic,... · General Hospital
Apr 2021 101d
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