FDA Product Code DRX: Electrode, Electrocardiograph
Leading manufacturers include Graphic Controls Corp., Lectec Corp. and Labeltape Meditect, Inc..
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
Jun 11, 2010
AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X
Ambu A/S
Cardiovascular
143d
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
Nov 07, 2008
TELECTRODE WET GEL ECG ELECTRODE
Bio Protech, Inc.
Cardiovascular
14d
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
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
Cleared
Apr 07, 2006
MACTRODE 3
Ge Medical Systems Information Technologies
Cardiovascular
25d
Cleared
Dec 14, 2005
PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20
Bio Protech, Inc.
Cardiovascular
49d
Cleared
Sep 02, 2005
ACCU-LEAD
Kentec Medical, Inc.
Cardiovascular
192d
Cleared
May 25, 2005
ELECTRODE
Electramold
Cardiovascular
111d
Cleared
Mar 22, 2005
ACCUHEART ELECTRODE BELT
Advanced Bioelectric Corporation
Cardiovascular
105d
Cleared
Sep 22, 2004
AMBU DISPOSABLE ECG ELECTRODE
Ambu, Inc.
Cardiovascular
89d
Cleared
Sep 15, 2004
DISPOSABLE MONITORING ELECTRODES
Shanghai Intco Electrode Manufacturing Co., Ltd.
Cardiovascular
57d
Cleared
Jun 28, 2004
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
Ambu, Inc.
Cardiovascular
68d
Cleared
Apr 07, 2004
PROTAB ECG TABB ELECTRODE
Bio Protech, Inc.
Cardiovascular
9d
Cleared
Feb 24, 2004
SKINTACT ECG ELECTRODE
Leonhard Lang GmbH
Cardiovascular
21d
Cleared
Mar 04, 2003
SKINTACT ECG TAB ELECTRODE
Leonhard Lang GmbH
Cardiovascular
13d
Cleared
Jan 16, 2003
SKINTACT
Leonhard Lang GmbH
Cardiovascular
52d
Cleared
Jan 16, 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
Leonhard Lang GmbH
Cardiovascular
24d