ClearanceBrief
Panels › General Hospital › Product code FMI · Class 2

Needle, Hypodermic, Single Lumen

Regulation 880.5570

13510(k)s in 12 months (694 all time)
3recalls in 12 months (311 all time)
283recalls that name a 510(k)
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Top companies in FMI

Company510(k)sRecalls
Kendall Healthcare Products Co091
Multi-Med, Inc.275
Becton, Dickinson & CO1016
Cardinal Health 200, LLC023
International Medsurg Connection220
Bd Becton Dickinson Vacutainer Systems Preanalytic200
Vidacare Corporation142
B.Braun Medical, Inc.510
Terumo Europe N.V.150
Terumo Medical Corp.410
Decided510(k)Device and applicantCode
Sep 17, 2026K261266MOWANA™ Auto Duo
PENTAMASTER MEDIQ SDN BHD, MY
FMI
Aug 25, 2026K261719Promisemed X-Safety Pen Needle
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Aug 10, 2026K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safet
Hh Global Technology, Inc.
FMI
Aug 7, 2026K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051
Hangzhou Qiantang Longyue Biotechnology Co., Ltd., CN
FMI
Jul 29, 2026K261829Profoject™ Dual-Safety Pen Needles
CMT Health PTE., Ltd., SG
FMI
Jul 15, 2026K260739Profoject™ Pen Needles (Model A; Model B)
CMT Health PTE., Ltd., SG
FMI
Jun 10, 2026K260855Profoject™ Safety Pen Needles
CMT Health PTE., Ltd., SG
FMI
Apr 16, 2026K254273Verisafe Safety Sterile Needles (SSN)
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Mar 25, 2026K252908Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
Sandstone Medical (Suzhou), Inc., CN
FMI
Mar 24, 2026K253047PRESSONE™
Nipro Medical Corporation
FMI
Mar 18, 2026K253622Safety Pen Needle
Ningbo Medsun Medical Co., Ltd., CN
FMI
Jan 6, 2026K252886Pen Needle
Hh Global Technology, Inc.
FMI
Nov 21, 2025K250700Pen Injector Needle 32.5
Terumo Corporation, JP
FMI
Oct 16, 2025K252631Profoject™ Disposable Needle
CMT Health PTE., Ltd., SG
FMI
Jul 30, 2025K250724Intraosseous Infusion Needles
Spectrum Vascular
FMI
Jul 24, 2025K250284TSK SELECT™ Needle
Tsk Laboratory, Japan, JP
FMI
Jul 8, 2025K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
Terumo Europe N.V., BE
FMI
May 29, 2025K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)
Terumo Europe N.V., BE
FMI
Apr 18, 2025K240355FROG (Filter Removal of Glass)
Carrtech Corp
FMI
Apr 4, 2025K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)
Terumo Europe N.V., BE
FMI
Apr 3, 2025K250658SureFine Pen Needle
Shina Med Corporation, KR
FMI
Jan 10, 2025K243806Safety Winged Blood Collection Sets
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Jan 8, 2025K242741ACE Cannula
Ace Medical Industry Co., Ltd., KR
FMI
Sep 26, 2024K242632Verifine® Pen Needles
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Jul 2, 2024K240915ZIEN IO Intraosseous Access System
Zien Medical Technologies, Inc.
FMI
Feb 1, 2024K232165Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile
Berpu Medical Technology Co., Ltd., CN
FMI
Dec 12, 2023K233037Sterile Hypodermic Needles for Single Use
Zhejiang Kindly Medical Device Co., Ltd., CN
FMI
Nov 27, 2023K233343SteriCap Safety Needle; VitreJect Safety Needle
Ocuject, LLC
FMI
Oct 5, 2023K230070MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM®
Promamedical, Inc.
FMI
Sep 20, 2023K230043Insulin Pen Needle
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., CN
FMI
Sep 14, 2023K230959VitreJect® Needle; OcuSafe® Needle
Ocuject, LLC
FMI
Sep 8, 2023K231729Sterile syringes for single use with/without needle
Wepon Medical Technology Co., Ltd., CN
FMI
Sep 8, 2023K231723Sterile Safety Hypodermic Needles for Single Use
Wepon Medical Technology Co., Ltd., CN
FMI
Sep 8, 2023K231720Sterile Hypodermic Needles for Single Use
Wepon Medical Technology Co., Ltd., CN
FMI
Aug 25, 2023K231255NovoFine® Plus
Novo Nordisk, Inc.
FMI
Jul 27, 2023K231261Altaviz Needle Kit II
Altaviz, LLC
FMI
Jul 25, 2023K231924EZ-IO Intraosseous Vascular Access System
Teleflex Medical
FMI
Jun 2, 2023K230635Pen Needle
Jiangsu Caina Medical Co.,Ltd, CN
FMI
May 25, 2023K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
Nipro Medical Corporation
FMI
Apr 6, 2023K222739Disposable Insulin Pen Needle
Hantech Medical Device Co., Ltd., CN
FMI
Mar 20, 2023K222417Shina Safety Needle
Shina Corporation, KR
FMI
Feb 16, 2023K223327Sterile Aesthetic Cannula and Hypodermic Needle
Shanghai Kindly Enterprise Development Group Co., Ltd., CN
FMI
Feb 15, 2023K222271Verisafe Safety sterile needles
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Jan 20, 2023K203792Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
Pikdare Spa, IT
FMI
Dec 28, 2022K223286BD AutoShield Duo™ Pen Needle
Becton, Dickinson and Company
FMI
Dec 16, 2022K223334Sterile Hypodermic Needles for Single Use
Zhejiang Kindly Medical Devices Co., Ltd., CN
FMI
Dec 13, 2022K214004CCBIO ASCPO Needle
Cc Biotechnology Corporation, TW
FMI
Dec 5, 2022K222681Altaviz Needle Kit
Altaviz, LLC
FMI
Dec 2, 2022K223353DropSafeTM SicuraTM
Pikdare Spa, IT
FMI
Nov 17, 2022K221178Disposable Insulin Pen Needle
Ningbo Medsun Medical Co., Ltd., CN
FMI

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