FDA Product Code FMF: Syringe, Piston
Under FDA product code FMF, piston syringes are cleared for the aspiration and injection of fluids in clinical settings.
These devices consist of a cylindrical barrel and a sliding plunger that creates suction or pressure to draw in or expel liquids. They are used for medication injection, wound irrigation, aspiration of body fluids, and enteral feeding across all care settings.
FMF devices are Class II medical devices, regulated under 21 CFR 880.5860 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Bd Becton Dickinson Vacutainer Systems Preanalytic, Becton, Dickinson and Company and Promisemed Hangzhou Meditech Co., Ltd..
750
Total
750
Cleared
124d
Avg days
1976
Since
750 devices
Cleared
Apr 05, 2019
EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
Flat Medical Co., Ltd.
General Hospital
227d
Cleared
Mar 14, 2019
BD Plastipak Syringe
Becton, Dickinson and Company
General Hospital
175d
Cleared
Dec 17, 2018
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
Novo Nordisk, Inc.
General Hospital
104d
Cleared
Nov 20, 2018
Orbit Subretinal Delivery System
Orbit Biomedical, Inc.
Ophthalmic
90d
Cleared
Nov 06, 2018
Merit Syringe
Merit Medical Systems, Inc.
General Hospital
83d
Cleared
Nov 06, 2018
Merit Syringe
Merit Medical Systems, Inc.
General Hospital
76d
Cleared
Oct 23, 2018
BD Single Use, Hypodermic Syringe
Becton, Dickinson and Company
General Hospital
413d
Cleared
May 10, 2018
Graftgun Universal Graft Delivery System
SurGenTec, LLC
General Hospital
30d
Cleared
Mar 30, 2018
Nipro Syringe
Nipro Medical Corporation
General Hospital
183d
Cleared
Jan 31, 2018
Merit Syringe
Merit Medical Systems, Inc.
General Hospital
71d
Cleared
Aug 07, 2017
Merit Syringe
Merit Medical Systems, Inc.
General Hospital
90d
Cleared
Aug 27, 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
Biomet, Inc.
General Hospital
57d
Cleared
May 16, 2012
ARTHREX MIXING AND DELIVERY SYSTEM
Arthrex, Inc.
General Hospital
33d
Cleared
Mar 12, 2010
COAXIAL APPLICATOR SYSTEM
Biomet, Inc.
General Hospital
274d
Cleared
Dec 06, 2007
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
Biomet, Inc.
General Hospital
108d
Cleared
Feb 26, 2007
CAPTION APPLICATOR
Smith & Nephew, Inc.
General Hospital
96d
Cleared
Sep 29, 2006
ARTHREX ASPIRATE KIT
Arthrex, Inc.
General Hospital
46d
Cleared
Aug 23, 2006
MODIFICATION TO BONE GRAFT SYRINGE
Wrightmedicaltechnologyinc
General Hospital
23d
Cleared
Jul 19, 2006
MEDLINE SYRINGES, MULTIPLE
Medline Industries, Inc.
General Hospital
72d
Cleared
Feb 10, 2006
MODIFICATION TO: VACLOK SYRINGE
Wrightmedicaltechnologyinc
General Hospital
28d
Cleared
Jul 25, 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
Synthes (Usa)
General Hospital
28d
Cleared
Aug 23, 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
Smith & Nephew, Inc.
General Hospital
32d
Cleared
Oct 02, 2002
BONE GRAFT SYRINGE, MODEL 8600-00X0
Wrightmedicaltechnologyinc
General Hospital
15d
Cleared
Jul 01, 2002
PCCS GRAFT DELIVERY SYSTEM
Biomet, Inc.
General Hospital
90d