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
Apr 16, 2023K221974EpiFinder
Omeq Medical , Ltd., IL
FMF
Mar 23, 2023K212207Sterile Hypodermic Syringe for Single Use
Shandong Weigao Group Medical Polymer Co., Ltd., CN
FMF
Mar 6, 2023K222672Disposable Insulin Syringe
Hantech Medical Device Co., Ltd., CN
FMF
Mar 2, 2023K223453Insulin Syringe
Promisemed Hangzhou Meditech Co., Ltd., CN
FMF
Feb 25, 2023K221702CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific, Inc.
FMF
Feb 13, 2023K212635Sofjec
Hwajin Medical Co., Ltd., KR
FMF
Feb 9, 2023K223678Sterile Syringes for Single Use
Shanghai Kindly Enterprise Development Group Co., Ltd., CN
FMF
Feb 9, 2023K203211Insulin syringe with integrated needle DL
Dlp Medical Products, Corp.
FMF
Dec 9, 2022K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
Medline Industries, Inc.
FMF
Nov 4, 2022K212764Medwell Technology Ltd Syringes, various sizes
Medwell Technology, Ltd., CN
FMF
Nov 3, 2022K221045Insulin Syringes without needle
Berpu Medical Technology Co., Ltd., CN
FMF
Oct 17, 2022K221308Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Jiangxi Maidikang Medical Devices Co., Ltd., CN
FMF
Oct 11, 2022K222744Sol-M Luer Lock Syringe
Sol-Millennium Medical, Inc.
FMF
Oct 4, 2022K221079Sterile Hypodermic Syringes for Single Use
Sichuan Prius Biotechnology Co., Ltd., CN
FMF
Oct 4, 2022K221068Sterile Hypodermic Syringes for Single Use with Needles
Sichuan Prius Biotechnology Co., Ltd., CN
FMF
Aug 30, 2022K212846Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
Jiangsu Jichun Medical Devices Co., Ltd., CN
FMF
Aug 17, 2022K212033Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle
Shandong Zhushi Pharmaceutical Group Co., Ltd., CN
FMF
Aug 11, 2022K221737InstaFill Graft Delivery System, SIGNIFY Bioactive
Globus Medical, Inc.
FMF
Jul 21, 2022K220184Pump Alignment Syringe
Jiangsu Caina Medical Co.,Ltd, CN
FMF
Jul 21, 2022K213158Syringe with permanently attached needle
Berpu Medical Technology Co., Ltd., CN
FMF
Jul 14, 2022K220204Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
Anhui Tiankang Medical Technology Co., Ltd., CN
FMF
May 12, 2022K213811Sterile Hypodermic Syringes for Single Use
Berpu Medical Technology Co., Ltd., CN
FMF
Apr 15, 2022K212677aboNT SYRINGE
Nipro Medical Corporation
FMF
Apr 5, 2022K213560Verifine Safety Syringe with Fixed Needle
Promisemed Hangzhou Meditech Co., Ltd., CN
FMF
Mar 14, 2022K203738Qitexio
Medex, FR
FMF
Mar 11, 2022K212920Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable
Shandong Weigao Group Medical Polymer Co., Ltd., CN
FMF
Mar 9, 2022K212499BD Insulin Syringe (0.3mL)
Becton, Dickinson and Company
FMF
Mar 1, 2022K210848Sure-Fine Insulin Syringes
Shina Med Corporation, KR
FMF
Feb 10, 2022K213632Instylla Delivery Kit
Instylla, Inc.
FMF
Jan 27, 2022K211210Sterile Auto-Disable Syringes with/without Needle for Single Use
Azur Medical Company, Inc.
FMF
Jan 24, 2022K211482Disposable Syringe with Needle
Shandong Qinkai Medical Industry Co., Ltd., CN
FMF
Jan 18, 2022K201044CHIRANA Insulin Syringes
Chirana T. Injecta, SK
FMF
Dec 17, 2021K210914Sterile Syringe for Single Use
Jiangsu Suyun Medical Material Co., Ltd., CN
FMF
Oct 13, 2021K212544MiniLoad Syringe
Ocuject, LLC
FMF
Oct 7, 2021K211211Sterile syringes for single use with/without needle
Azur Medical Company, Inc.
FMF
Oct 5, 2021K211728Sterile hypodermic syringes for single use
Jiangsu Kangyou Medical Instrument Co., Ltd., CN
FMF
Sep 15, 2021K210818TrueCare Biomedix Tamper Evident Cap
Us Infusion Inc. D/B/A Truecare Biomedix-USA
FMF
Sep 10, 2021K210227Sterile syringe for single use with/without needle
Zhejiang Kangkang Medical-Devices Co., Ltd., CN
FMF
Sep 9, 2021K211242Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
Promisemed Hangzhou Meditech Co., Ltd., CN
FMF
Sep 8, 2021K210712Verifine Mechanical Safety Insulin Syringe
Promisemed Hangzhou Meditech Co., Ltd., CN
FMF
Sep 7, 2021K210997PreferX Delivery System
Md3, LLC
FMF
Aug 26, 2021K210991Disposable Sterile Syringe, Disposable Sterile Syringe with Needle
Guangdong Antmed Co., Ltd., CN
FMF
Aug 24, 2021K210464Auto Disable Syringe
Anhui Tiankang Medical Technology Co., Ltd., CN
FMF
Jul 28, 2021K203359BD Flu+ Syringe
Becton, Dickinson and Company
FMF
Jul 16, 2021K210103SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX
Lifelong Meditech Private Limited, IN
FMF
May 14, 2021K2102001 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock
Set Medikal Sanayi VE Ticaret Anonim Sirketi, TR
FMF
Apr 26, 2021K203264MicroDose Injector
Medone Surgical, Inc.
FMF
Feb 19, 2021K202432MiniLoad Syringe
Ocuject, LLC
FMF
Jan 25, 2021K203453BD Hypodermic Syringe
Becton, Dickinson and Company
FMF
Jan 17, 2021K201930Nanum Syringe
Nanum Company Co., Ltd., KR
FMF

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