| FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
| K220083 |
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. |
LDV((Low Dead Volume )Syringe |
05/25/2022 |
| K213010 |
Feeltech Co., Ltd. |
FEELject LDV (Low dead volume) syringe |
05/31/2023 |
| K213013 |
Jeil Tech Co., Ltd. |
Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe |
09/19/2022 |
| K231856 |
MedExel Co., Ltd. |
TopFine« LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) |
03/15/2024 |
| K210443 |
Poonglim Pharmatech Inc. |
PLPT LDV (Low Dead Volume) Sterile Syringe |
02/16/2021 |
| K221860 |
Poonglim Pharmatech Inc. |
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe |
09/15/2023 |
| K241190 |
Poonglim Pharmatech Inc. |
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe |
05/29/2024 |
| K250138 |
Prosum Medical Limited |
Small Volume 0.2mL Syringe |
04/02/2025 |
| K232943 |
Smiths Medical ASD Inc |
Hypodermic Needle-Pro« EDGEÖ Safety Device with Low Dead Space Syringe |
05/31/2024 |
| K242291 |
Sol-Millennium Medical Inc. |
SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (L |
11/20/2024 |