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
337–360 of 756
Cleared Jul 24, 1997
CORELIFE
K964230
Core Healthcare , Ltd.
General Hospital · 274d
Cleared Jul 24, 1997
RAMY INTEGRATED NEEDLE SYRINGE
K972452
Alshifa Medical Syringes Mfg. Co., Ltd.
General Hospital · 78d
Cleared Mar 04, 1997
BRANNON ARTERIO-VENOUS PORTSYRINGE
K965030
Vascular Logics, Inc.
General Hospital · 77d
Cleared Feb 10, 1997
OMNICAN SYRINGE
K962084
B. Braun Medical AG
General Hospital · 257d
Cleared Dec 24, 1996
COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE
K964060
Travenol Laboratories (Israel) , Ltd.
General Hospital · 76d
Cleared Dec 19, 1996
IRT LOCKING SYRINGE
K945410
Interventional Research Technologies
General Hospital · 777d
Cleared Nov 22, 1996
DRESSING CHANGE TRAYS
K963260
Busse Hospital Disposables, Inc.
General Hospital · 94d
Cleared Oct 08, 1996
GLASS SYRINGE
K962042
Ispg, Inc.
General Hospital · 133d
Cleared Sep 12, 1996
GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10
K962329
Global Medical Prods, Inc.
General Hospital · 87d
Cleared Sep 06, 1996
SHIFA STERILE DISPOSABLE SYRINGES
K962614
International Regulatory Consultants
General Hospital · 65d
Cleared Jul 25, 1996
PISTON SYRINGE
K955606
Medical Surgical Intl.
General Hospital · 230d
Cleared Jul 08, 1996
CONTROL SYRINGE
K960882
Louisville Laboratories, Inc.
General Hospital · 139d
Cleared May 24, 1996
BRANNON PEDI PORTSYRINGE
K960047
James K. Brannon
General Hospital · 143d
Cleared May 24, 1996
BRANNON PORTSYRINGE
K960049
James K. Brannon
General Hospital · 143d
Cleared May 21, 1996
TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
K953940
Terumo Medical Corp.
General Hospital · 274d
Cleared May 06, 1996
THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
K955282
Thermogenesis Corp.
General Hospital · 172d
Cleared Apr 12, 1996
GENERAL PROCEDURE KIT
K960248
Physician Industries, Inc.
General Hospital · 87d
Cleared Mar 20, 1996
S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)
K955164
Habley Medical Technology Corp.
General Hospital · 128d
Cleared Feb 16, 1996
UNIQUE NEEDLE WITH FIRM GRIP SHIELD
K950666
Unique Management Ent., Inc.
General Hospital · 368d
Cleared Nov 21, 1995
BECTON DICKINSON SYRINGSE
K954064
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 83d
Cleared Nov 13, 1995
GENOTROPIN MIXER
K954337
Pharmacia, Inc.
General Hospital · 56d
Cleared Oct 24, 1995
B-D PEN ULTRA
K951919
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital · 183d
Cleared Oct 19, 1995
PISTON SYRINGE
K951025
Pharmacia, Inc.
General Hospital · 227d
Cleared Sep 15, 1995
PTFE SYRINGE FILTER
K952918
B.Braun Medical, Inc.
General Hospital · 81d