FDA Product Code DRX: Electrode, Electrocardiograph
Leading manufacturers include Graphic Controls Corp., Nikomed U.S.A., Inc. and Lectec Corp..
329
Total
329
Cleared
123d
Avg days
1976
Since
FDA 510(k) Cleared Electrode, Electrocardiograph Devices (Product Code DRX)
329 devices
Cleared
Aug 23, 2017
Physiotrace
Nimbleheart, Inc.
Cardiovascular
117d
Cleared
Jul 24, 2014
HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
Hmicro, Inc.
Cardiovascular
191d
Cleared
Apr 24, 2013
BIOMODULE 3-M1
Zephyr Technology Corporation
Cardiovascular
147d
Cleared
Jul 22, 2010
CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
Team Innovations, Inc.
Cardiovascular
45d
Cleared
Jul 01, 2010
IP-SET
Integral Process Sas
Cardiovascular
15d
Cleared
Jun 11, 2010
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
Ambu A/S
Cardiovascular
143d
Cleared
May 10, 2010
INTCO TAB ELECTRODE
Shanghai Intco Electrode Manufacturing Co., Ltd.
Cardiovascular
196d
Cleared
Apr 23, 2010
12 LEAD GLOVE
I Needmd, Inc.
Cardiovascular
78d
Cleared
Dec 10, 2009
NEONATAL ECG ELECTRODE, M203KEN
R & D Medical Products, Inc.
Cardiovascular
93d
Cleared
Oct 13, 2009
DISPOSAL ECG ELECTRODES, MODEL EASYRODE
Suzuken Co., Ltd.
Cardiovascular
69d
Cleared
Sep 01, 2009
QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH
Cardiac Lead Technologies, Inc.
Cardiovascular
188d
Cleared
Aug 21, 2009
SKINTACT AND VARIOUS OTHER TRADENAMES
Leonhard Lang GmbH
Cardiovascular
23d
Cleared
Aug 07, 2009
CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
Conmed Corporation
Cardiovascular
45d
Cleared
Jun 17, 2009
TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
Vermed, Inc.
Cardiovascular
145d
Cleared
Mar 10, 2009
PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
Commwell , Ltd.
Cardiovascular
89d
Cleared
Nov 07, 2008
TELECTRODE WET GEL ECG ELECTRODE
Bio Protech, Inc.
Cardiovascular
14d
Cleared
Sep 25, 2008
AUDICOR SENSOR, MODELS: 2.0, 3.0
Inovise Medical, Inc.
Cardiovascular
206d
Cleared
Feb 01, 2008
SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
Leonhard Lang GmbH
Cardiovascular
17d
Cleared
Nov 16, 2007
SKINTACT AND VARIOUS OTHER TRADENAMES
Leonhard Lang GmbH
Cardiovascular
14d
Cleared
Nov 02, 2007
TEXTRONICS ECG ELECTRODE
Textronics, Inc.
Cardiovascular
147d
Cleared
Mar 23, 2007
CARDIOBELT ELECTRODE BELT
Monebo Technologies, Inc.
Cardiovascular
170d
Cleared
Dec 11, 2006
ORI F6T DRY ECG MONITORING ELECTRODE
Orbital Research, Inc.
Cardiovascular
87d
Cleared
Oct 25, 2006
AMBU WHITE SENSOR CFM, CFL
Ambu A/S
Cardiovascular
370d
Cleared
Oct 25, 2006
AMBU BLUE SENSOR NEO AND NEO X
Ambu A/S
Cardiovascular
309d