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)
Get daily alerts for FMISample briefCSV

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
Nov 4, 2022K222124Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., CN
FMI
Oct 31, 2022K220890IO Needle Safety Sheath
Actuated Medical, Inc.
FMI
Oct 14, 2022K213183Safety Insulin Pen Needles
Zhejiang Kindly Medical Devices Co., Ltd., CN
FMI
Oct 4, 2022K221080Sterile Safety Hypodermic Needles for Single Use
Sichuan Prius Biotechnology Co., Ltd., CN
FMI
Oct 4, 2022K221066Sterile Hypodermic Needles for Single Use
Sichuan Prius Biotechnology Co., Ltd., CN
FMI
Sep 19, 2022K220129Promisemed X-Safety Pen Needle
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Aug 23, 2022K220603Disposable Medical Safety Hypodermic Needle
Hantech Medical Device Co., Ltd., CN
FMI
Aug 22, 2022K212095SurGuard3 Safety Hypodermic Needle
Terumo Europe N.V., BE
FMI
Jul 1, 2022K221176Insulin Pen Needle
Tianjin Huahong Technology Co., Ltd., CN
FMI
Jun 28, 2022K213478BD Pen Needle
Becton, Dickinson and Company
FMI
Jun 15, 2022K220614MEDOJECT fine Pen Needles
Chirana T. Injecta, SK
FMI
May 25, 2022K210748Well-life TM Pen Needles, Well-life TM Safety Pen Needles
W. L. Med Co., Ltd., KR
FMI
May 13, 2022K213535Sterile Safety Hypodermic Needles for Single Use
Zhejiang Kangkang Medical-Devices Co., Ltd., CN
FMI
Apr 29, 2022K212514Safety Pen Needle for Single Use, Insulin Pen Needles
Berpu Medical Technology Co., Ltd., CN
FMI
Apr 12, 2022K214075Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needl
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., CN
FMI
Feb 17, 2022K210864Safety Pen Needle
Sandstone Medical (Suzhou), Inc., CN
FMI
Jan 7, 2022K211716DropSafe Safety Pen Needles
Htl Strefa SA, PL
FMI
Dec 16, 2021K213407UltiCare Disposable Pen Needles
Ultimed Incorporated
FMI
Dec 14, 2021K200932Blood Collection Needles
Vacutest Kima Srl, IT
FMI
Dec 8, 2021K213156BD Nano 2nd Gen Pen Needle
Becton, Dickinson and Company
FMI
Nov 19, 2021K212015BD Nano 2nd Gen Pen Needle
Becton, Dickinson and Company
FMI
Nov 12, 2021K202319Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
Tianjin Huahong Technology Co., Ltd., CN
FMI
Oct 14, 2021K211214Sterile Hypodermic Needles for Single Use
Azur Medical Company, Inc.
FMI
Sep 30, 2021K212805SteriCap Mini Needle and Standard Needles
Ocuject, LLC
FMI
Sep 23, 2021K210232Sterile Hypodermic Needles for Single Use
Zhejiang Kangkang Medical-Devices Co., Ltd., CN
FMI
Sep 17, 2021K210399Unifine SafeControl
Owen Mumford, Ltd., GB
FMI
Aug 26, 2021K211634Hypodermic Needle-Pro EDGE Safety Device
Smiths Medical Asd, Inc.
FMI
Jul 28, 2021K211395NIO-I
Einstein Works, LLC
FMI
Jul 22, 2021K211968NIO+ Adult
Waismed, Ltd., IL
FMI
Jul 21, 2021K210059Promisemed Insulin Pen Needle
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Jun 25, 2021K211293Safety Winged Blood Collection Sets
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Jun 23, 2021K210258NovoFine
Novo Nordisk, Inc.
FMI
Apr 22, 2021K210065Verifine Safety Type Insulin Pen Needle
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Mar 22, 2021K202492EZ-IO Intraosseous Vascular Access System
Teleflex Medical
FMI
Feb 2, 2021K193422Easydrip Pen Needle, Easydrip Plus Pen Needle
Sandstone Medical (Suzhou), Inc., CN
FMI
Dec 31, 2020K202681Promisemed Covered Safety Pen Needle
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Dec 19, 2020K202005NovoFine Plus 32G Tip x 4 mm
Novo Nordisk, Inc.
FMI
Nov 24, 2020K202682Promisemed Triple Safety Pen Needle
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Nov 5, 2020K200017Eclipse DermaFlex Cannula
Eclipse Medcorp, LLC
FMI
Oct 15, 2020K202340Droplet Pen Needle 30G & 33G
Htl-Strefa S.A, PL
FMI
Aug 25, 2020K192464Injection Pen Needle
Gangan Medical Technology Jiangsu Co., Ltd., CN
FMI
Aug 6, 2020K191644TK Safety Needle
Anhui Tiankang Medical Technology Co., Ltd., CN
FMI
May 12, 2020K192222EZ-Inject Single use Needle
Poonglim Pharmatech, Inc., KR
FMI
Apr 21, 2020K192082Droplet Pen Needle 34G
Htl-Strefa S.A, PL
FMI
Feb 3, 2020K190962Bella-mu
U-Needle B.V., NL
FMI
Dec 19, 2019K191643TK Sterile Hypodermic Needle
Anhui Tiankang Medical Technology Co., Ltd., CN
FMI
Nov 21, 2019K191488SAM IO Intraosseous Access System
Sam® Medical Products, Inc.
FMI
Nov 13, 2019K191976Piper GO-IO Intraosseous Infusion System
Piper Access, LLC
FMI
Oct 23, 2019K191258Intraosseous infusion device
Einstein Works, LLC
FMI
Oct 11, 2019K192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1
Terumo Europe N.V., BE
FMI

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.