FMF
- 产品代码
- FMF
- 器械名称
- Syringe, Piston
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.5860
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 752 件
该代码近三年的 510(k)（43 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K262581 | 2026-08-26 | SurGenTec, LLC | GraftGun Universal Graft Delivery System (GDS®) 摘要 |
| K252184 | 2026-08-25 | Sol-Millennium Medical, Inc. | SOL-M Luer Lock Syringe with Exchangeable Needle Tra 摘要 |
| K253747 | 2026-08-14 | Jiangsu Enjosim Medical Technology Co. | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) 摘要 |
| K260208 | 2026-07-13 | embecta Medical II, LLC | Ultra-Fine SAFETY Insulin Syringe 摘要 |
| K253110 | 2026-06-18 | Sol-Millennium Medical, Inc. | Sol-Glide Safety Needle; Sol-Glide Safety Needle wit 摘要 |
| K260514 | 2026-06-12 | CMT Health PTE., Ltd. | Profoject Safety Needle; Profoject Syringe with Sa 摘要 |
| K253112 | 2026-05-21 | Hlb Lifescience Co., Ltd. | Sofjec (Single use Needle); Sofjec (Single use Syrin 摘要 |
| K252279 | 2026-04-17 | Chirana T.Injecta,A.S. | Sterile Hypodermic Syringe for Single Use (20ml, 30m 摘要 |
| K253068 | 2026-02-23 | CMT Health PTE., Ltd. | Profoject Insulin Syringes; Profoject Safelock Dis 摘要 |
| K253769 | 2025-12-22 | Instylla, Inc. | Instylla Delivery Kit 摘要 |
| K252518 | 2025-12-17 | Duopross Meditech Corporate | DuoprossTM Smart Cap (Type I) 摘要 |
| K251089 | 2025-12-12 | Exelint International, Co. | EXEL Disposable Syringe; EXEL Disposable Syringe wit 摘要 |
| K250192 | 2025-12-10 | Promisemed Hangzhou Meditech Co., Ltd. | Verisafe Safety Retractable Insulin Syringes 摘要 |
| K250853 | 2025-11-04 | Merit Medical Systems, Inc. | Merit Syringe 摘要 |
| K250510 | 2025-10-15 | Shina Med Corporation | Sure-Fine Insulin Syringes 摘要 |
| K243660 | 2025-08-22 | Cardinalhealth | Monoject 1mL Tuberculin Syringe Luer-Lock Tip (118 |
| K251350 | 2025-07-29 | Becton, Dickinson and Company | BD Plastipak Syringe 摘要 |
| K252033 | 2025-07-25 | CMT Health PTE., Ltd. | Profoject Disposable Syringe, Profoject Disposable 摘要 |
| K250733 | 2025-07-03 | Bimed Teknik Aletler Sanayi & Ticaret | 3DOSE 1ml Syringe 摘要 |
| K251648 | 2025-06-24 | Prosidyan, Inc. | GPS Advanced; GPS Advanced Cannula 摘要 |
| K250262 | 2025-04-24 | Go-Pen Aps | GO-PEN® 摘要 |
| K243580 | 2025-02-05 | SurGenTec, LLC | GraftGun Universal Graft Delivery System (GDS) 摘要 |
| K242434 | 2024-12-24 | Chirana T. Injecta | Insulin Syringes 摘要 |
| K241856 | 2024-12-23 | Hlb Lifescience Co., Ltd. | Sofjec (Single use Needle); Sofjec (Single use Syrin 摘要 |
| K242099 | 2024-10-22 | Sol-Millennium Medical, Inc. | Sol-M Slip Tip Syringe without Needle, Sol-M Eccen 摘要 |
| K241821 | 2024-09-20 | Sol-Millennium Medical, Inc. | Luer Lock Syringe with Safety Needle; Luer Lock Syri 摘要 |
| K231095 | 2024-09-04 | International Medical Industries, Inc. | Tamper Evident Cap 摘要 |
| K240961 | 2024-08-15 | Wuxi Nest Biotechnology Co., Ltd. | Disposable Pen Injector Assembly 摘要 |
| K241426 | 2024-07-10 | Prosidyan, Inc. | GPS Advanced; 5 cc GPS Advanced Cannula 摘要 |
| K233368 | 2024-06-25 | Bioventus, LLC | Allograft Delivery Device (OFAC-C) 摘要 |
| K240774 | 2024-06-18 | Wuxi Nest Biotechnology Co., Ltd. | Pen Injector 摘要 |
| K232950 | 2024-06-12 | Perfect Medical Industry (Vn) Co., Ltd | Sterile Disposable Syringe, Sterile Disposable Syrin 摘要 |
| K234024 | 2024-03-19 | Anhui Hongyu Wuzhou Medical Manufactur | HWJECT Auto-disable syringe 摘要 |
| K233794 | 2024-03-06 | Spm Medicare Pvt. , Ltd. | Insulin Syringe 摘要 |
| K230235 | 2024-02-16 | Medline Industries, LP | Medline Luer Lock Syringes 摘要 |
| K231558 | 2024-01-12 | Smb Corporation of India | SMB Luer lock disposable syringe 摘要 |
| K230061 | 2023-11-30 | Anhui Hongyu Wuzhou Medical Manufactur | Insulin Syringe 摘要 |
| K231877 | 2023-11-30 | Lineage Biomedical, Inc. | NavaClick Injection System 摘要 |
| K231519 | 2023-11-06 | Revital Healthcare (Epz) Limited | Revital Cady 摘要 |
| K233056 | 2023-11-02 | Guidestar Medical Devices | EpiZact 摘要 |
| K221777 | 2023-10-06 | Weihai Shengjie Medical Technology Co. | Disposable Sterile Syringe 摘要 |
| K231792 | 2023-09-28 | Promisemed Hangzhou Meditech Co., Ltd. | VeriSafe Safety sterile syringes 摘要 |
| K231888 | 2023-09-25 | Care Fusion | BD Texium Needle-Free Syringe 摘要 |
FDA 官方分类页： FMF
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。