FMF · Class II · 21 CFR 880.5860

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, Sherwood Medical Co. and Becton, Dickinson and Company.

756
Total
756
Cleared
124d
Avg days
1976
Since
756 devices
193–216 of 756
Cleared Aug 13, 2013
EVICEL APPLICATION DEVICE
K130900
Ethicon Inc (On Behalf of Omrix Biopharaceuticals
General Hospital · 134d
Cleared May 09, 2013
UNITOX BOTOX SYRINGE
K123710
Bio-Med USA, Inc.
General Hospital · 156d
Cleared May 03, 2013
ARTIGLASS L. O.R. GLASS SYRINGE
K122416
Artiglass Srl
General Hospital · 268d
Cleared Feb 19, 2013
INTRADERMAL ADAPTER
K123588
West Pharmaceutical Services, Inc.
General Hospital · 90d
Cleared Feb 14, 2013
MONOJECT 12ML SYRINGE
K130049
Nipro Medical Corporation
General Hospital · 37d
Cleared Dec 06, 2012
COMFORT EZ
K122787
Simple Diagnostics, Inc.
General Hospital · 86d
Cleared Nov 09, 2012
REGEN SPRAY APPLICATOR,
K122122
Regen Lab SA
General Hospital · 115d
Cleared Oct 04, 2012
MIXJECT WITH SPRAY HEAD
K122023
Medimop Medical Projects, Ltd.
General Hospital · 85d
Cleared Sep 20, 2012
NEOMED ORAL/ENTERAL SYRINGE
K122373
Neomed, Inc.
General Hospital · 45d
Cleared Aug 29, 2012
INFILL GRAFT DELIVERY SYSTEM
K121476
Pinnacle Spine Group, LLC
General Hospital · 103d
Cleared Aug 03, 2012
MYSAFETY SYRINGE
K113673
Medicalchain Internartional Corporation
General Hospital · 234d
Cleared May 30, 2012
BD EMERALD SAF-T SINGLE USE, HYPODERMIC
K121283
Becton, Dickinson and Company
General Hospital · 30d
Cleared May 16, 2012
ARTHREX MIXING AND DELIVERY SYSTEM
K121124
Arthrex, Inc.
General Hospital · 33d
Cleared Mar 01, 2012
SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K111841
Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.
General Hospital · 246d
Cleared Dec 14, 2011
KDL SYRINGES AND NEEDLE
K112057
Shanghai Kindly Enterprise Dev. Group Co.,
General Hospital · 148d
Cleared Nov 28, 2011
BD EMERALD SINGLE USE, HYPODERMIC SYRINGE
K113241
Becton Dickinson
General Hospital · 26d
Cleared Nov 10, 2011
XTRACT SYRINGE KEY SYSTEM
K112475
Xtract Solutions
General Hospital · 73d
Cleared Oct 28, 2011
SYRINGES AND NEEDLES
K113091
Jiangyin Caina Technology Co., Ltd.
General Hospital · 9d
Cleared Aug 18, 2011
IMC INSULIN SYRINGE
K110882
International Medsurg Connection
General Hospital · 141d
Cleared Aug 11, 2011
INFILL GRAFT DELIVERY SYSTEM
K111632
Pinnacle Spine Group, LLC
General Hospital · 59d
Cleared Jul 29, 2011
JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)
K103830
Jiangsu Shenli Medical Production Factory
General Hospital · 211d
Cleared Jul 14, 2011
TIGER SYRINGES AND NEEDLES
K110697
Tiger Medical Products, Ltd.
General Hospital · 122d
Cleared Jun 24, 2011
MERIT MEDICAL 20 ML SYRINGE
K111091
Merit Medical Systems, Inc.
General Hospital · 66d
Cleared Jun 10, 2011
DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE
K103736
Dmc Medical, Ltd.
General Hospital · 170d