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
Oct 7, 2019K190538NIO-I
Waismed, Ltd., IL
FMI
Sep 5, 2019K191853Dual-Safety Pen Needle
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
May 7, 2019K183016SteriCap Mini Needle
Ocujet, LLC
FMI
Apr 9, 2019K182770Adult Intraosseous Infusion Device
Einstein Works, LLC
FMI
Mar 12, 2019K181447Safety insulin needle for single use
Berpu Medical Technology Co., Ltd., CN
FMI
Mar 1, 2019K181730BD Vacutainer Eclipse UltraFill Blood Collection Needle
Becton, Dickinson and Company
FMI
Feb 13, 2019K181508U&U Blood Collection Sets
U&U Medical Technology Co, Ltd., CN
FMI
Dec 20, 2018K182320BD Contoured Base Pen Needle
Becton, Dickinson and Company
FMI
Dec 3, 2018K182146Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with H
Sol-Millennium Medical, Inc.
FMI
Nov 13, 2018K181369Immucise Intradermal Injection System
Terumo Corporation, JP
FMI
Nov 9, 2018K180395EZ-IO Intraosseous Vascular Access System
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
FMI
Aug 28, 2018K181069Disposable Insulin Pen Needle
Zhejiang Kindly Medical Devices Co., Ltd., CN
FMI
Aug 20, 2018K170824BD Vacutainer Eclipse Signal Blood Collection Needle
Becton, Dickinson and Company
FMI
Aug 3, 2018K163578EasyTouch Safety Pen Needle
Mhc Medical Products, LLC
FMI
Jul 24, 2018K172095Autokeeper
Medexel Co.,Ltd, KR
FMI
Jul 11, 2018K173881Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G
Owen Mumford, Ltd., GB
FMI
Jun 27, 2018K180720Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel
Medibio USA, LLC
FMI
Jun 21, 2018K172483Kopac Sterile Needle
Poonglim Pharmatech, Inc., KR
FMI
Jun 14, 2018K172938Disposable Sterile Needle
Jiangsu Caina Medical Co.,Ltd, CN
FMI
Jun 11, 2018K173803Omnican fine
B.Braun Medical, Inc.
FMI
May 21, 2018K180545VACUETTE SAFELINK Holder with male luer lock
Greiner Bio-One Na, Inc.
FMI
May 18, 2018K180259Sterile Hypodermic Needle for Single Use
Jiangsu Shenli Medical Production Co., Ltd., CN
FMI
May 14, 2018K173279RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
Myco Medical Supplies, Inc.
FMI
Apr 19, 2018K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set
Greiner Bio-One Na, Inc.
FMI
Apr 17, 2018K180588FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device
Teleflex Medical
FMI
Mar 21, 2018K171982DROPLET PEN NEEDLE
Htl-Strefa S.A, PL
FMI
Jan 17, 2018K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
Novo Nordisk, Inc.
FMI
Dec 12, 2017K170988DropSafe Safety Pen Needle
Htl-Strefa S.A, PL
FMI
Dec 11, 2017K170276Safety Blood Collection Device for Single Use
Gemtier Medical (Shanghai), Inc., CN
FMI
Oct 11, 2017K171984Clickfine Pen Needle, Penfine Classic Pen Needle
Ypsomed AG, CH
FMI
Sep 12, 2017K171144Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel
Medbio, LLC
FMI
Jul 10, 2017K170768Mini Needle
Ocuject, LLC
FMI
May 11, 2017K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
Promisemed Hangzhou Meditech Co., Ltd., CN
FMI
Mar 14, 2017K163093Safety Blood Collection Set
Jiangsu Shenli Medical Production Co., Ltd., CN
FMI
Jan 19, 2017K161255meso-relle (AAL34, AAL36, AM30G)
Biotekne Srl, IT
FMI
Dec 9, 2016K162516BD Pen Needle
Becton, Dickinson and Company
FMI
Nov 3, 2016K160532Greiner Holdex
Greiner Bio-One Na, Inc.
FMI
Oct 19, 2016K160199Advocate Insulin Pen Needles
Diabetic Supply of Suncoast, Inc.
FMI
Sep 21, 2016K151090CPL Insulin Pen Needle
Cpl Co., Ltd., KR
FMI
Sep 7, 2016K160575CareSens Pen Needle, Softip Pen Needle
Yidobio, Inc., KR
FMI
Aug 29, 2016K153706Insulin Pen Needle
SteriLance Medical (Suzhou), Inc., CN
FMI
Jul 26, 2016K160887Cook Intraosseous Infusion Needles
Cook Incorporated
FMI
Jul 11, 2016K152166JSM Insulin Pen Needle
Jeesung Medical Co., Ltd., KR
FMI
Jul 6, 2016K161553BD SafeAssist
Becton, Dickinson and Company
FMI
Jun 24, 2016K152339Unifine Pentips/ Unifine Pentips Plus
Owen Mumford, Ltd., GB
FMI
Jun 23, 2016K160805NIO-P
Waismed, Ltd., IL
FMI
Jun 8, 2016K152597ProteXsure Safety Capsule System
Starcap Medical, LLC ( Dba Prism Medical & Design)
FMI
Jun 7, 2016K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAF
Guangzhou Improve Medical Instruments Co., Ltd., CN
FMI
Jun 7, 2016K152877SureFine Pen Needle
Shina Med Corporation, KR
FMI
May 27, 2016K161170BD Eclipse Hypodermic Needle
Becton, Dickinson and Company
FMI

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