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
Jan 7, 2021K202544Instylla Delivery Kit
Instylla, Inc.
FMF
Jan 5, 2021K193273Insulin Syringe
Promisemed Hangzhou Meditech Co., Ltd., CN
FMF
Dec 17, 2020K192770S dispensing line
Aea Srl, IT
FMF
Dec 14, 2020K201284Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use,
Set Medikal Sanayi VE Ticaret Anonim Sirketi, TR
FMF
Oct 16, 2020K201816ARTHROTAP
Accuro Technologies, Inc., CA
FMF
Sep 3, 2020K2019003D GraftRasp System
Surgentec
FMF
Jul 17, 2020K193526Syringe with safety needle, Safety needle
Jiangsu Caina Medical Co.,Ltd, CN
FMF
Jul 15, 2020K201234BD SoloShot Mini Syringe/ BD Auto Disable Syringe
Becton, Dickinson and Company
FMF
Jul 14, 2020K200325Orbit Subretinal Delivery System
Orbit Biomedical
FMF
Jul 13, 2020K201338Allograft MIS Delivery System
Lifenet Health
FMF
May 29, 2020K200629Aspire Mechanical Aspirator G
Control Medical Technology
FMF
May 18, 2020K2004313D GraftRasp System
Surgentec
FMF
May 1, 2020K200606O-Genesis Graft Delivery System
Orthofix, Inc.
FMF
Mar 5, 2020K193101Omnifix Low Dead Space Luer Lock Syringe
B.Braun Medical, Inc.
FMF
Feb 18, 2020K192674Mixing and Delivery System
Bone Solutions, Inc.
FMF
Jan 31, 2020K193192Tamper Evident Cap
International Medical Industries, Inc.
FMF
Jan 6, 2020K191642TK Sterile Piston Syringe without Needle
Anhui Tiankang Medical Technology Co., Ltd., CN
FMF
Oct 21, 2019K190054BD Insulin Syringe
Becton, Dickinson and Company
FMF
Oct 10, 2019K191659Instylla Delivery Kit
Instylla, Inc.
FMF
Oct 9, 2019K191359Nipro Syringe
Nipro Medical Corporation
FMF
Sep 27, 2019K192421EpiFaith Syringe
Flat Medical Co., Ltd., TW
FMF
Sep 12, 2019K190002Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Ste
Shanghai Kohope Medical Devices Co., Ltd., CN
FMF
Sep 6, 2019K191531Sure-Fine Insulin Syringes
Shina Med Corporation, KR
FMF
Sep 3, 2019K1827655cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,
Top Corporation, JP
FMF
Jul 28, 2019K190996Bonus Therapeutics Mixing and Delivery System
Bonus Therapeutics , Ltd., IL
FMF
Jul 18, 2019K190427Immucise
Terumo Corporation, JP
FMF
Apr 5, 2019K182268EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
Flat Medical Co., Ltd., TW
FMF
Mar 14, 2019K182589BD Plastipak Syringe
Becton, Dickinson and Company
FMF
Dec 17, 2018K182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
Novo Nordisk, Inc.
FMF
Nov 20, 2018K182274Orbit Subretinal Delivery System
Orbit Biomedical, Inc.
FMF
Nov 6, 2018K182279Merit Syringe
Merit Medical Systems, Inc.
FMF
Nov 6, 2018K182216Merit Syringe
Merit Medical Systems, Inc.
FMF
Oct 23, 2018K172670BD Single Use, Hypodermic Syringe
Becton, Dickinson and Company
FMF
May 10, 2018K180937Graftgun Universal Graft Delivery System
SurGenTec, LLC
FMF
Mar 30, 2018K173029Nipro Syringe
Nipro Medical Corporation
FMF
Jan 31, 2018K173601Merit Syringe
Merit Medical Systems, Inc.
FMF
Nov 30, 2017K173385Graft Delivery, DePuy Synthes
Micromedics, Inc. (D/B/A Nordson Medical)
FMF
Nov 9, 2017K170900DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Acc
Intervene Group, Ltd., GB
FMF
Nov 8, 2017K171131MHC Standard and NRFit Tip Syringes
Mazza Healthcare, LLC
FMF
Sep 8, 2017K171805Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml
Conceptomed AS, NO
FMF
Aug 7, 2017K171362Merit Syringe
Merit Medical Systems, Inc.
FMF
Jul 19, 2017K170675Graftgun Universal Graft Delivery System
SurGenTec, LLC
FMF
Jun 9, 2017K161883CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific, Inc.
FMF
Apr 12, 2017K170386BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle an
Becton Dickinson & Company
FMF
Mar 27, 2017K161812Freedom Syringe
Procedure Products, Inc.
FMF
Mar 20, 2017K163161Sterile Single-use Syringe with Needle
Jiangxi Hongda Medical Equipment Group , Ltd., CN
FMF
Feb 24, 2017K170218Vesco Medical NRFit Tip Syringes
Vesco Medical, LLC
FMF
Feb 10, 2017K161606Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
Terumo Europe N.V., BE
FMF
Jan 11, 2017K162057ConceptoMed Luer-Jack Slip 10ml
Conceptomed AS, NO
FMF
Dec 29, 2016K162180Disposable Insulin Syringe
Berpu Medical Technology Co., Ltd., CN
FMF

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