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

Syringe, Piston

Regulation 880.5860

14510(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
Aug 26, 2026K262581GraftGun Universal Graft Delivery System (GDS®)
SurGenTec, LLC
FMF
Aug 25, 2026K252184SOL-M Luer Lock Syringe with Exchangeable Needle Tray
Sol-Millennium Medical, Inc.
FMF
Aug 14, 2026K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
Jiangsu Enjosim Medical Technology Co., Ltd., CN
FMF
Jul 13, 2026K260208Ultra-Fine™ SAFETY Insulin Syringe
embecta Medical II, LLC
FMF
Jun 18, 2026K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe
Sol-Millennium Medical, Inc.
FMF
Jun 12, 2026K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle
CMT Health PTE., Ltd., SG
FMF
May 21, 2026K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
Hlb Lifescience Co., Ltd., KR
FMF
Apr 17, 2026K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
Chirana T.Injecta,A.S., SK
FMF
Feb 23, 2026K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe
CMT Health PTE., Ltd., SG
FMF
Dec 22, 2025K253769Instylla Delivery Kit
Instylla, Inc.
FMF
Dec 17, 2025K252518DuoprossTM Smart Cap (Type I)
Duopross Meditech Corporate
FMF
Dec 12, 2025K251089EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle;
Exelint International, Co.
FMF
Dec 10, 2025K250192Verisafe Safety Retractable Insulin Syringes
Promisemed Hangzhou Meditech Co., Ltd., CN
FMF
Nov 4, 2025K250853Merit Syringe
Merit Medical Systems, Inc.
FMF
Oct 15, 2025K250510Sure-Fine Insulin Syringes
Shina Med Corporation, KR
FMF
Aug 22, 2025K243660Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syringe, Luer-Lock Tip (1180300777); Monoje
Cardinalhealth
FMF
Jul 29, 2025K251350BD Plastipak™ Syringe
Becton, Dickinson and Company
FMF
Jul 25, 2025K252033Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
CMT Health PTE., Ltd., SG
FMF
Jul 3, 2025K2507333DOSE 1ml Syringe
Bimed Teknik Aletler Sanayi & Ticaret A.S., TR
FMF
Jun 24, 2025K251648GPS Advanced; GPS Advanced Cannula
Prosidyan, Inc.
FMF
Apr 24, 2025K250262GO-PEN®
Go-Pen Aps, DK
FMF
Feb 5, 2025K243580GraftGun Universal Graft Delivery System (GDS)
SurGenTec, LLC
FMF
Dec 24, 2024K242434Insulin Syringes
Chirana T. Injecta, SK
FMF
Dec 23, 2024K241856Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
Hlb Lifescience Co., Ltd., KR
FMF
Oct 22, 2024K242099Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle
Sol-Millennium Medical, Inc.
FMF
Sep 20, 2024K241821Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Need
Sol-Millennium Medical, Inc.
FMF
Sep 4, 2024K231095Tamper Evident Cap
International Medical Industries, Inc.
FMF
Aug 15, 2024K240961Disposable Pen Injector Assembly
Wuxi Nest Biotechnology Co., Ltd., CN
FMF
Jul 10, 2024K241426GPS Advanced; 5 cc GPS Advanced Cannula
Prosidyan, Inc.
FMF
Jun 25, 2024K233368Allograft Delivery Device (OFAC-C)
Bioventus, LLC
FMF
Jun 18, 2024K240774Pen Injector
Wuxi Nest Biotechnology Co., Ltd., CN
FMF
Jun 12, 2024K232950Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
Perfect Medical Industry (Vn) Co., Ltd., VN
FMF
Mar 19, 2024K234024HWJECT Auto-disable syringe
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., CN
FMF
Mar 6, 2024K233794Insulin Syringe
Spm Medicare Pvt. , Ltd., IN
FMF
Feb 16, 2024K230235Medline Luer Lock Syringes
Medline Industries, LP
FMF
Jan 12, 2024K231558SMB Luer lock disposable syringe
Smb Corporation of India, IN
FMF
Nov 30, 2023K231877NavaClick Injection System
Lineage Biomedical, Inc.
FMF
Nov 30, 2023K230061Insulin Syringe
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd., CN
FMF
Nov 6, 2023K231519Revital Cady
Revital Healthcare (Epz) Limited, KE
FMF
Nov 2, 2023K233056EpiZact
Guidestar Medical Devices, CA
FMF
Oct 6, 2023K221777Disposable Sterile Syringe
Weihai Shengjie Medical Technology Co., Ltd., CN
FMF
Sep 28, 2023K231792VeriSafe Safety sterile syringes
Promisemed Hangzhou Meditech Co., Ltd., CN
FMF
Sep 25, 2023K231888BD Texium™ Needle-Free Syringe
Care Fusion
FMF
Sep 8, 2023K231727Sterile Auto-Disable Syringes with/without Needle for Single Use
Wepon Medical Technology Co., Ltd., CN
FMF
Jul 25, 2023K231900A-TAP (previously called Arthrotap)
Elcam Medical Acal, IL
FMF
Jul 18, 2023K222925Hypodermic Syringes & Needle
Lifelong Meditech Private Limited, IN
FMF
Jul 17, 2023K231456Avitus® DragonWing Large Volume Autograft Delivery System
Avitus Orthopaedics, Inc.
FMF
Jun 26, 2023K230492Avitus® Precision Autograft Delivery System
Avitus Orthopaedics, Inc.
FMF
May 9, 2023K212857Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use
Jiangsu Zhiyu Medical Instrument Co, Ltd., CN
FMF
May 4, 2023K220713Sol-Guard Auto-disable Syringe
Sol-Millennium Medical, Inc.
FMF

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