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
241–264 of 756
Cleared Dec 08, 2006
MEDTRONIC GRAFT DELIVERY SYRINGE
K062986
Medtronic Sofamor Danek USA, Inc.
General Hospital · 70d
Cleared Nov 17, 2006
INJEKT SYRINGE
K063280
B.Braun Medical, Inc.
General Hospital · 17d
Cleared Sep 29, 2006
ARTHREX ASPIRATE KIT
K062365
Arthrex, Inc.
General Hospital · 46d
Cleared Sep 13, 2006
BAXTER DUPLOSPRAY MIS APPLICATOR
K061092
Micromedics, Inc.
General Hospital · 147d
Cleared Aug 23, 2006
MODIFICATION TO BONE GRAFT SYRINGE
K062173
Wrightmedicaltechnologyinc
General Hospital · 23d
Cleared Jul 19, 2006
MEDLINE SYRINGES, MULTIPLE
K061275
Medline Industries, Inc.
General Hospital · 72d
Cleared Jun 29, 2006
AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE
K061039
Amsino International, Inc.
General Hospital · 76d
Cleared Apr 06, 2006
TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES
K053413
Terumo Europe N.V.
General Hospital · 120d
Cleared Feb 10, 2006
MODIFICATION TO: VACLOK SYRINGE
K060095
Wrightmedicaltechnologyinc
General Hospital · 28d
Cleared Jan 24, 2006
B. BRAUN 0.2 MICRON FILTER
K052773
B.Braun Medical, Inc.
General Hospital · 113d
Cleared Oct 19, 2005
VITAGEL SURGICAL HEMOSTAT SPRAY SET
K052173
Orthovita, Inc.
General Hospital · 70d
Cleared Sep 02, 2005
YI XIN STERILE SYRINGE FOR SINGLE USE
K050999
Jiangxi Sanxin (Eversincere) Medical Devices Group
General Hospital · 135d
Cleared Aug 26, 2005
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K051574
Nipro Medical Corp.
General Hospital · 73d
Cleared Aug 16, 2005
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034
Terumo Medical Corp.
General Hospital · 19d
Cleared Jul 25, 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720
Synthes (Usa)
General Hospital · 28d
Cleared Jun 15, 2005
CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063
K050998
Confluent Surgical,Inc
General Hospital · 56d
Cleared May 18, 2005
STRYKER DISCMONITOR
K050753
Stryker Instruments
General Hospital · 56d
Cleared May 02, 2005
EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
K050495
Baxter Healthcare Corp., Bioscience
General Hospital · 63d
Cleared Mar 11, 2005
HARVEST GRAFT DELIVERY SYRINGE
K043261
Harvest Technologies, Corp.
General Hospital · 107d
Cleared Feb 22, 2005
DUOPROSS SYRINGES
K042500
Duopross Meditech Corporation
General Hospital · 161d
Cleared Jan 21, 2005
PROCEDUR 10 SYRINGE DEVICE
K042486
Avanca Medical Devices, Inc.
General Hospital · 130d
Cleared Jan 07, 2005
TRUGRAFT BGS SYRINGE, MODEL 600-041
K043172
Osteobiologics, Inc.
General Hospital · 52d
Cleared Dec 09, 2004
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093
K042588
Confluent Surgical,Inc
General Hospital · 78d
Cleared Dec 01, 2004
DRAGON HEART PISTON SYRINGE
K042547
Dragon Heart Medical Devices Co., Ltd.
General Hospital · 72d