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
Dec 17, 2020
S dispensing line
Aea Srl
General Hospital
444d
Cleared
Dec 14, 2020
Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use
Set Medikal Sanayi VE Ticaret Anonim Sirketi
General Hospital
215d
Cleared
Oct 16, 2020
ARTHROTAP
Accuro Technologies, Inc.
General Hospital
107d
Cleared
Sep 03, 2020
3D GraftRasp System
Surgentec
Orthopedic
57d
Cleared
Jul 17, 2020
Syringe with safety needle, Safety needle
Jiangsu Caina Medical Co.,Ltd
General Hospital
211d
Cleared
Jul 15, 2020
BD SoloShot Mini Syringe/ BD Auto Disable Syringe
Becton, Dickinson and Company
General Hospital
69d
Cleared
Jul 14, 2020
Orbit Subretinal Delivery System
Orbit Biomedical
Ophthalmic
155d
Cleared
Jul 13, 2020
Allograft MIS Delivery System
Lifenet Health
General & Plastic Surgery
54d
Cleared
May 29, 2020
Aspire Mechanical Aspirator G
Control Medical Technology
General Hospital
80d
Cleared
May 18, 2020
3D GraftRasp System
Surgentec
General & Plastic Surgery
87d
Cleared
May 01, 2020
O-Genesis Graft Delivery System
Orthofix, Inc.
General & Plastic Surgery
53d
Cleared
Mar 05, 2020
Omnifix Low Dead Space Luer Lock Syringe
B.Braun Medical, Inc.
General Hospital
118d
Cleared
Feb 18, 2020
Mixing and Delivery System
Bone Solutions, Inc.
General & Plastic Surgery
145d
Cleared
Jan 31, 2020
Tamper Evident Cap
International Medical Industries, Inc.
General Hospital
73d
Cleared
Jan 06, 2020
TK Sterile Piston Syringe without Needle
Anhui Tiankang Medical Technology Co., Ltd.
General Hospital
201d
Cleared
Oct 21, 2019
BD Insulin Syringe
Becton, Dickinson and Company
General Hospital
283d
Cleared
Oct 10, 2019
Instylla Delivery Kit
Instylla, Inc.
General Hospital
111d
Cleared
Oct 09, 2019
Nipro Syringe
Nipro Medical Corporation
General Hospital
141d
Cleared
Sep 27, 2019
EpiFaith Syringe
Flat Medical Co., Ltd.
Anesthesiology
23d
Cleared
Sep 12, 2019
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
Shanghai Kohope Medical Devices Co., Ltd.
General Hospital
253d
Cleared
Sep 06, 2019
Sure-Fine Insulin Syringes
Shina Med Corporation
General Hospital
88d
Cleared
Sep 03, 2019
5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
Top Corporation
General Hospital
340d
Cleared
Jul 28, 2019
Bonus Therapeutics Mixing and Delivery System
Bonus Therapeutics , Ltd.
Orthopedic
103d
Cleared
Jul 18, 2019
Immucise
Terumo Corporation
General Hospital
146d