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FMI

Needle, Hypodermic, Single Lumen

产品代码
FMI
器械名称
Needle, Hypodermic, Single Lumen
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 880.5570
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)
30 件
其中 Summary 已存档
27 份,可直接下载
FDA 历史累计 510(k)
693 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(30 件)

数据窗口为最近三年。最新一件:2026-08-25。

510(k) 号批准日期申请人器械名称摘要
K2617192026-08-25Promisemed Hangzhou Meditech Co., Ltd.Promisemed X-Safety Pen NeedlePDF
K2624272026-08-10Hh Global Technology, Inc.Pen Needle (Ordinary Type I, Safety Type IIA, Safety…PDF
K2609332026-08-07Hangzhou Qiantang Longyue Biotechnolog…Safety Sterile Hypodermic Needles (NR-S1816R, NR-S19…PDF
K2618292026-07-29CMT Health PTE., Ltd.Profoject™ Dual-Safety Pen NeedlesPDF
K2607392026-07-15CMT Health PTE., Ltd.Profoject™ Pen Needles (Model A; Model B)PDF
K2608552026-06-10CMT Health PTE., Ltd.Profoject™ Safety Pen NeedlesPDF
K2542732026-04-16Promisemed Hangzhou Meditech Co., Ltd.Verisafe Safety Sterile Needles (SSN)—
K2529082026-03-25Sandstone Medical (Suzhou), Inc.Easydrip Classic Pen Needle; Easydrip Plus Pen Needl…PDF
K2530472026-03-24Nipro Medical CorporationPRESSONE™FDA
K2536222026-03-18Ningbo Medsun Medical Co., Ltd.Safety Pen NeedlePDF
K2528862026-01-06Hh Global Technology, Inc.Pen NeedlePDF
K2507002025-11-21Terumo CorporationPen Injector Needle 32.5PDF
K2526312025-10-16CMT Health PTE., Ltd.Profoject™ Disposable NeedlePDF
K2507242025-07-30Spectrum VascularIntraosseous Infusion NeedlesPDF
K2502842025-07-24Tsk Laboratory, JapanTSK SELECT™ NeedlePDF
K2514472025-07-08Terumo Europe N.V.K-Pack Embrace Active Safety Needle (KNAS-2516RB, KN…PDF
K2433092025-05-29Terumo Europe N.V.27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)FDA
K2403552025-04-18Carrtech CorpFROG (Filter Removal of Glass)PDF
K2435812025-04-04Terumo Europe N.V.K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC…PDF
K2506582025-04-03Shina Med CorporationSureFine Pen NeedlePDF
K2438062025-01-10Promisemed Hangzhou Meditech Co., Ltd.Safety Winged Blood Collection SetsPDF
K2427412025-01-08Ace Medical Industry Co., Ltd.ACE CannulaPDF
K2426322024-09-26Promisemed Hangzhou Meditech Co., Ltd.Verifine® Pen NeedlesPDF
K2409152024-07-02Zien Medical Technologies, Inc.ZIEN IO Intraosseous Access SystemPDF
K2321652024-02-01Berpu Medical Technology Co., Ltd.Sterile Safety Hypodermic Needles for Single Use; St…PDF
K2330372023-12-12Zhejiang Kindly Medical Device Co., Lt…Sterile Hypodermic Needles for Single UsePDF
K2333432023-11-27Ocuject, LLCSteriCap Safety Needle; VitreJect Safety NeedlePDF
K2300702023-10-05Promamedical, Inc.MESORAM® Hypodermic Needle (710301); MESORAM® Hypode…PDF
K2300432023-09-20Anhui Hongyu Wuzhou Medical Manufactur…Insulin Pen NeedlePDF
K2309592023-09-14Ocuject, LLCVitreJect® Needle; OcuSafe® NeedlePDF

其中 27 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: FMI
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。