FDA Product Code
FDA Product Code FMF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5860
510(k) Clearances — 752 records · page 1 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | 2026-08-26 | Special | PDF ↗ |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | 2026-08-25 | Traditional | PDF ↗ |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | 2026-08-14 | Traditional | PDF ↗ |
| K260208 | Ultra-Fine SAFETY Insulin Syringe | embecta Medical II, LLC | 2026-07-13 | Traditional | PDF ↗ |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026-06-18 | Traditional | PDF ↗ |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | 2026-06-12 | Traditional | PDF ↗ |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2026-05-21 | Special | PDF ↗ |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | 2026-04-17 | Traditional | PDF ↗ |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | 2026-02-23 | Traditional | PDF ↗ |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025-12-22 | Special | PDF ↗ |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | 2025-12-17 | Traditional | PDF ↗ |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | 2025-12-12 | Traditional | PDF ↗ |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 | Traditional | PDF ↗ |
| K250853 | Merit Syringe | Merit Medical Systems, Inc. | 2025-11-04 | Special | PDF ↗ |
| K250510 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2025-10-15 | Special | PDF ↗ |
| K243660 | Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoject 6mL Syringe, Luer-Lock Tip (1180600777); Monoject 12mL Syringe, Luer-Lock Tip (1181200777); Monoject 20mL Syringe, Luer-Lock Tip (1182000777); Monoject 35mL Syringe, Luer-Lock Tip (1183500777); Monoject 60mL Syringe, Luer-Lock Tip (1186000777); Monoject 3mL Syringe, Luer-Lock Tip (8881513934); Monoject 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | Cardinalhealth | 2025-08-22 | Traditional | PDF ↗ |
| K251350 | BD Plastipak Syringe | Becton, Dickinson and Company | 2025-07-29 | Traditional | PDF ↗ |
| K252033 | Profoject Disposable Syringe, Profoject Disposable Syringe with Needle | CMT Health PTE., Ltd. | 2025-07-25 | Traditional | PDF ↗ |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | 2025-07-03 | Traditional | PDF ↗ |
| K251648 | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | 2025-06-24 | Special | PDF ↗ |
| K250262 | GO-PEN® | Go-Pen Aps | 2025-04-24 | Traditional | PDF ↗ |
| K243580 | GraftGun Universal Graft Delivery System (GDS) | SurGenTec, LLC | 2025-02-05 | Traditional | PDF ↗ |
| K242434 | Insulin Syringes | Chirana T. Injecta | 2024-12-24 | Special | PDF ↗ |
| K241856 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | 2024-12-23 | Special | PDF ↗ |
| K242099 | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle | Sol-Millennium Medical, Inc. | 2024-10-22 | Traditional | PDF ↗ |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle | Sol-Millennium Medical, Inc. | 2024-09-20 | Traditional | PDF ↗ |
| K231095 | Tamper Evident Cap | International Medical Industries, Inc. | 2024-09-04 | Traditional | PDF ↗ |
| K240961 | Disposable Pen Injector Assembly | Wuxi Nest Biotechnology Co., Ltd. | 2024-08-15 | Traditional | PDF ↗ |
| K241426 | GPS Advanced; 5 cc GPS Advanced Cannula | Prosidyan, Inc. | 2024-07-10 | Traditional | PDF ↗ |
| K233368 | Allograft Delivery Device (OFAC-C) | Bioventus, LLC | 2024-06-25 | Traditional | PDF ↗ |
| K240774 | Pen Injector | Wuxi Nest Biotechnology Co., Ltd. | 2024-06-18 | Traditional | PDF ↗ |
| K232950 | Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle | Perfect Medical Industry (Vn) Co., Ltd. | 2024-06-12 | Traditional | PDF ↗ |
| K234024 | HWJECT Auto-disable syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2024-03-19 | Traditional | PDF ↗ |
| K233794 | Insulin Syringe | Spm Medicare Pvt. , Ltd. | 2024-03-06 | Traditional | PDF ↗ |
| K230235 | Medline Luer Lock Syringes | Medline Industries, LP | 2024-02-16 | Traditional | PDF ↗ |
| K231558 | SMB Luer lock disposable syringe | Smb Corporation of India | 2024-01-12 | Traditional | PDF ↗ |
| K230061 | Insulin Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-11-30 | Traditional | PDF ↗ |
| K231877 | NavaClick Injection System | Lineage Biomedical, Inc. | 2023-11-30 | Traditional | PDF ↗ |
| K231519 | Revital Cady | Revital Healthcare (Epz) Limited | 2023-11-06 | Traditional | PDF ↗ |
| K233056 | EpiZact | Guidestar Medical Devices | 2023-11-02 | Traditional | PDF ↗ |
| K221777 | Disposable Sterile Syringe | Weihai Shengjie Medical Technology Co., Ltd. | 2023-10-06 | Traditional | PDF ↗ |
| K231792 | VeriSafe Safety sterile syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2023-09-28 | Traditional | PDF ↗ |
| K231888 | BD Texium Needle-Free Syringe | Care Fusion | 2023-09-25 | Traditional | PDF ↗ |
| K231727 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Wepon Medical Technology Co., Ltd. | 2023-09-08 | Traditional | PDF ↗ |
| K231900 | A-TAP (previously called Arthrotap) | Elcam Medical Acal | 2023-07-25 | Special | PDF ↗ |
| K222925 | Hypodermic Syringes & Needle | Lifelong Meditech Private Limited | 2023-07-18 | Traditional | PDF ↗ |
| K231456 | Avitus® DragonWing Large Volume Autograft Delivery System | Avitus Orthopaedics, Inc. | 2023-07-17 | Traditional | PDF ↗ |
| K230492 | Avitus® Precision Autograft Delivery System | Avitus Orthopaedics, Inc. | 2023-06-26 | Traditional | PDF ↗ |
| K212857 | Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use | Jiangsu Zhiyu Medical Instrument Co, Ltd. | 2023-05-09 | Traditional | PDF ↗ |
| K220713 | Sol-Guard Auto-disable Syringe | Sol-Millennium Medical, Inc. | 2023-05-04 | Traditional | PDF ↗ |
| K221974 | EpiFinder | Omeq Medical , Ltd. | 2023-04-16 | Traditional | PDF ↗ |
| K212207 | Sterile Hypodermic Syringe for Single Use | Shandong Weigao Group Medical Polymer Co., Ltd. | 2023-03-23 | Traditional | PDF ↗ |
| K222672 | Disposable Insulin Syringe | Hantech Medical Device Co., Ltd. | 2023-03-06 | Traditional | PDF ↗ |
| K223453 | Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | 2023-03-02 | Traditional | PDF ↗ |
| K221702 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | 2023-02-25 | Traditional | PDF ↗ |
| K212635 | Sofjec | Hwajin Medical Co., Ltd. | 2023-02-13 | Traditional | PDF ↗ |
| K203211 | Insulin syringe with integrated needle DL | Dlp Medical Products, Corp. | 2023-02-09 | Traditional | PDF ↗ |
| K223678 | Sterile Syringes for Single Use | Shanghai Kindly Enterprise Development Group Co., Ltd. | 2023-02-09 | Traditional | PDF ↗ |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe | Medline Industries, Inc. | 2022-12-09 | Traditional | PDF ↗ |
| K212764 | Medwell Technology Ltd Syringes, various sizes | Medwell Technology, Ltd. | 2022-11-04 | Traditional | PDF ↗ |
| K221045 | Insulin Syringes without needle | Berpu Medical Technology Co., Ltd. | 2022-11-03 | Traditional | PDF ↗ |
| K221308 | Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle | Jiangxi Maidikang Medical Devices Co., Ltd. | 2022-10-17 | Traditional | PDF ↗ |
| K222744 | Sol-M Luer Lock Syringe | Sol-Millennium Medical, Inc. | 2022-10-11 | Special | PDF ↗ |
| K221079 | Sterile Hypodermic Syringes for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 | Traditional | PDF ↗ |
| K221068 | Sterile Hypodermic Syringes for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 | Traditional | PDF ↗ |
| K212846 | Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use | Jiangsu Jichun Medical Devices Co., Ltd. | 2022-08-30 | Traditional | PDF ↗ |
| K212033 | Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2022-08-17 | Traditional | PDF ↗ |
| K221737 | InstaFill Graft Delivery System, SIGNIFY Bioactive | Globus Medical, Inc. | 2022-08-11 | Traditional | PDF ↗ |
| K220184 | Pump Alignment Syringe | Jiangsu Caina Medical Co.,Ltd | 2022-07-21 | Traditional | PDF ↗ |
| K213158 | Syringe with permanently attached needle | Berpu Medical Technology Co., Ltd. | 2022-07-21 | Traditional | PDF ↗ |
| K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle | Anhui Tiankang Medical Technology Co., Ltd. | 2022-07-14 | Traditional | PDF ↗ |
| K213811 | Sterile Hypodermic Syringes for Single Use | Berpu Medical Technology Co., Ltd. | 2022-05-12 | Traditional | PDF ↗ |
| K212677 | aboNT SYRINGE | Nipro Medical Corporation | 2022-04-15 | Traditional | PDF ↗ |
| K213560 | Verifine Safety Syringe with Fixed Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022-04-05 | Traditional | PDF ↗ |
| K203738 | Qitexio | Medex | 2022-03-14 | Traditional | PDF ↗ |
| K212920 | Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use | Shandong Weigao Group Medical Polymer Co., Ltd. | 2022-03-11 | Traditional | PDF ↗ |
| K212499 | BD Insulin Syringe (0.3mL) | Becton, Dickinson and Company | 2022-03-09 | Traditional | PDF ↗ |
| K210848 | Sure-Fine Insulin Syringes | Shina Med Corporation | 2022-03-01 | Special | PDF ↗ |
| K213632 | Instylla Delivery Kit | Instylla, Inc. | 2022-02-10 | Special | PDF ↗ |
| K211210 | Sterile Auto-Disable Syringes with/without Needle for Single Use | Azur Medical Company, Inc. | 2022-01-27 | Traditional | PDF ↗ |
| K211482 | Disposable Syringe with Needle | Shandong Qinkai Medical Industry Co., Ltd. | 2022-01-24 | Traditional | PDF ↗ |
| K201044 | CHIRANA Insulin Syringes | Chirana T. Injecta | 2022-01-18 | Traditional | PDF ↗ |
| K210914 | Sterile Syringe for Single Use | Jiangsu Suyun Medical Material Co., Ltd. | 2021-12-17 | Traditional | PDF ↗ |
| K212544 | MiniLoad Syringe | Ocuject, LLC | 2021-10-13 | Special | PDF ↗ |
| K211211 | Sterile syringes for single use with/without needle | Azur Medical Company, Inc. | 2021-10-07 | Traditional | PDF ↗ |
| K211728 | Sterile hypodermic syringes for single use | Jiangsu Kangyou Medical Instrument Co., Ltd. | 2021-10-05 | Traditional | PDF ↗ |
| K210818 | TrueCare Biomedix Tamper Evident Cap | Us Infusion Inc. D/B/A Truecare Biomedix-USA | 2021-09-15 | Traditional | PDF ↗ |
| K210227 | Sterile syringe for single use with/without needle | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2021-09-10 | Traditional | PDF ↗ |
| K211242 | Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2021-09-09 | Traditional | PDF ↗ |
| K210712 | Verifine Mechanical Safety Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | 2021-09-08 | Traditional | PDF ↗ |
| K210997 | PreferX Delivery System | Md3, LLC | 2021-09-07 | Traditional | PDF ↗ |
| K210991 | Disposable Sterile Syringe, Disposable Sterile Syringe with Needle | Guangdong Antmed Co., Ltd. | 2021-08-26 | Traditional | PDF ↗ |
| K210464 | Auto Disable Syringe | Anhui Tiankang Medical Technology Co., Ltd. | 2021-08-24 | Traditional | PDF ↗ |
| K203359 | BD Flu+ Syringe | Becton, Dickinson and Company | 2021-07-28 | Traditional | PDF ↗ |
| K210103 | SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX | Lifelong Meditech Private Limited | 2021-07-16 | Traditional | PDF ↗ |
| K210200 | 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock | Set Medikal Sanayi VE Ticaret Anonim Sirketi | 2021-05-14 | Special | PDF ↗ |
| K203264 | MicroDose Injector | Medone Surgical, Inc. | 2021-04-26 | Traditional | PDF ↗ |
| K202432 | MiniLoad Syringe | Ocuject, LLC | 2021-02-19 | Traditional | PDF ↗ |
| K203453 | BD Hypodermic Syringe | Becton, Dickinson and Company | 2021-01-25 | Traditional | PDF ↗ |
| K201930 | Nanum Syringe | Nanum Company Co., Ltd. | 2021-01-17 | Traditional | PDF ↗ |
Product code FMF · Class II · General Hospital. Data: openFDA.