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

Syringe, Piston

Regulation 880.5860

13510(k)s in 12 months (752 all time)
4recalls in 12 months (305 all time)
168recalls that name a 510(k)
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Top companies in FMF

Company510(k)sRecalls
Jiangsu Shenli Medical Production Co., Ltd.087
Becton Dickinson540
International Medsurg Connection338
Merit Medical Systems, Inc.1020
Bd Becton Dickinson Vacutainer Systems Preanalytic230
Sherwood Medical Co.200
Cardinal Health 200, LLC017
Becton, Dickinson and Co.140
Access Scientific LLC012
Sol-Millennium Medical, Inc.75
Decided510(k)Device and applicantCode
Dec 19, 2016K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypoderm
Becton, Dickinson and Company
FMF
Oct 18, 2016K162602NovoPen Echo
Novo Nordisk, Inc.
FMF
Sep 16, 2016K161568Bone Solutions Mixing and Delivery System
Bone Solutions, Inc.
FMF
Sep 9, 2016K152879Sure-Fine Insulin Syringes
Shina Med Corporation, KR
FMF
Jul 26, 2016K160629InPen
Companion Medical, Inc.
FMF
Jul 12, 2016K152803SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
Sung Shim Medicare Co., Ltd., KR
FMF
Jul 8, 2016K160978LITe BIO Delivery System
Stryker Corporation
FMF
Jul 8, 2016K151870BD U-500 INSULIN SYRINGE
Becton, Dickinson and Company
FMF
Jun 17, 2016K153537Sol-M Insulin Syringe, Sol-M TB Syringe
Sol-Millennium Medical, Inc.
FMF
Jun 3, 2016K160668HumaPen Savvio
Eli Lilly and Company, Inc.
FMF
May 17, 2016K153553SiO2 Coated syringe 3 ml
Sio2 Medical Products
FMF
Dec 30, 2015K151686HumanPen Ergo II
Eli Lilly and Company, Inc.
FMF
Dec 7, 2015K152783Merit 20 mL Syringe
Merit Medical Systems, Inc.
FMF
Sep 29, 2015K151777Intradermal Adapter
West Pharmaceutical Services, Inc.
FMF
Sep 2, 2015K151766BD Single Use, Hypodermic Syringe
Becton, Dickinson and Company
FMF
Jul 31, 2015K150874NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
Novo Nordisk, Inc.
FMF
Jul 7, 2015K151543Graft Delivery Device with Integrated Stylet
Micromedics, Inc. (D/B/A Nordson Medical)
FMF
Jun 5, 2015K142518HumaPen Luxura
Eli Lilly and Company
FMF
Apr 23, 2015K142535ConMed Mixing and Delivery Kit
Conmed Corporation
FMF
Jan 8, 2015K143757ANUTRA Feedback Aspiration Syringe
Anutra Medical, Inc.
FMF
Dec 17, 2014K143488InFill Graft Delivery System
Pinnacle Spine Group, LLC
FMF
Dec 11, 2014K142661Bi-Portal Bone Graft Delivery Device
Spinal Surgical Strategies, LLC
FMF
Oct 17, 2014K142636Merit 10mL Syringe
Merit Medical Systems, Inc.
FMF
Sep 4, 2014K140710BIOMET GRAFT DELIVERY SYRINGES
Biomet Spine (Aka Ebi, LLC)
FMF
Aug 27, 2014K141762PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
Biomet, Inc.
FMF
Jul 9, 2014K141245ETEX MIXING AND DELIVERY SYSTEM
Etex Corporation
FMF
Apr 14, 2014K140194NAMIC RCS SYRINGE
Navilyst Medical, Inc.
FMF
Mar 27, 2014K133493SINGLE USE STERILE SYRINGE WITH NEEDLE
Jiangxi Kelun Medical Devices Manufacturing Co.,Lt, CN
FMF
Mar 21, 2014K132011APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET
Aea Srl, IT
FMF
Feb 27, 2014K132553U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
U&U Medical Technology Co, Ltd., CN
FMF
Feb 20, 2014K132321JMS SYRINGE
JMS North America Corporation
FMF
Jan 13, 2014K133021MIXING SYRINGE SYSTEM
Zimmer Knee Creations, Inc.
FMF
Dec 12, 2013K132120WTF SECURA SYRINGE AND NEEDLE
Beijing Wantefu Medical Apparatus Co., Ltd., CN
FMF
Nov 20, 2013K130230STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
Wuxi Yushou Medical Applicances Co., Ltd., CN
FMF
Nov 5, 2013K131661INFUSION SYRINGE SET
Innovative Medical Manufacturing Co., TW
FMF
Oct 22, 2013K131963TAUTONA INJECTOR DEVICE
Tautona Group, LLC
FMF
Sep 12, 2013K124037JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
Jung Rim Medical Industrial Co., Ltd., KR
FMF
Aug 28, 2013K131641MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
Nipro Medical Corporation
FMF
Aug 15, 2013K123766NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
Novo Nordisk, Inc.
FMF
Aug 13, 2013K130900EVICEL APPLICATION DEVICE
Ethicon Inc (On Behalf of Omrix Biopharaceuticals
FMF
May 9, 2013K123710UNITOX BOTOX SYRINGE
Bio-Med USA, Inc.
FMF
May 3, 2013K122416ARTIGLASS L. O.R. GLASS SYRINGE
Artiglass Srl, IT
FMF
Feb 19, 2013K123588INTRADERMAL ADAPTER
West Pharmaceutical Services, Inc.
FMF
Feb 14, 2013K130049MONOJECT 12ML SYRINGE
Nipro Medical Corporation
FMF
Dec 6, 2012K122787COMFORT EZ
Simple Diagnostics, Inc.
FMF
Nov 9, 2012K122122REGEN SPRAY APPLICATOR,
Regen Lab SA, CA
FMF
Oct 4, 2012K122023MIXJECT WITH SPRAY HEAD
Medimop Medical Projects, Ltd., IL
FMF
Sep 20, 2012K122373NEOMED ORAL/ENTERAL SYRINGE
Neomed, Inc.
FMF
Aug 29, 2012K121476INFILL GRAFT DELIVERY SYSTEM
Pinnacle Spine Group, LLC
FMF
Aug 3, 2012K113673MYSAFETY SYRINGE
Medicalchain Internartional Corporation
FMF

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