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