Panels › Cardiovascular › Product code DRX · Class 2
Electrode, Electrocardiograph
Regulation 870.2360
0510(k)s in 12 months (329 all time)
0recalls in 12 months (20 all time)
19recalls that name a 510(k)
Top companies in DRX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 23, 2017 | K171244 | Physiotrace Nimbleheart, Inc. | DRX |
| Jul 24, 2014 | K140096 | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE Hmicro, Inc. | DRX |
| Apr 24, 2013 | K123658 | BIOMODULE 3-M1 Zephyr Technology Corporation | DRX |
| Jul 22, 2010 | K101576 | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES Team Innovations, Inc. | DRX |
| Jul 1, 2010 | K101685 | IP-SET Integral Process Sas, FR | DRX |
| Jun 11, 2010 | K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X Ambu A/S | DRX |
| May 10, 2010 | K093327 | INTCO TAB ELECTRODE Shanghai Intco Electrode Manufacturing Co., Ltd. | DRX |
| Apr 23, 2010 | K100315 | 12 LEAD GLOVE I Needmd, Inc. | DRX |
| Dec 10, 2009 | K092744 | NEONATAL ECG ELECTRODE, M203KEN R & D Medical Products, Inc. | DRX |
| Oct 13, 2009 | K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE Suzuken Co., Ltd., JP | DRX |
| Sep 1, 2009 | K090496 | QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH Cardiac Lead Technologies, Inc. | DRX |
| Aug 21, 2009 | K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES Leonhard Lang GmbH | DRX |
| Aug 7, 2009 | K091856 | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES Conmed Corporation | DRX |
| Jun 17, 2009 | K090180 | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE Vermed, Inc. | DRX |
| Mar 10, 2009 | K083677 | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 Commwell , Ltd. | DRX |
| Nov 7, 2008 | K083148 | TELECTRODE WET GEL ECG ELECTRODE Bio Protech, Inc., KR | DRX |
| Sep 25, 2008 | K080602 | AUDICOR SENSOR, MODELS: 2.0, 3.0 Inovise Medical, Inc. | DRX |
| Feb 1, 2008 | K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE Leonhard Lang GmbH | DRX |
| Nov 16, 2007 | K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES Leonhard Lang GmbH | DRX |
| Nov 2, 2007 | K071576 | TEXTRONICS ECG ELECTRODE Textronics, Inc. | DRX |
| Mar 23, 2007 | K063044 | CARDIOBELT ELECTRODE BELT Monebo Technologies, Inc. | DRX |
| Dec 11, 2006 | K062760 | ORI F6T DRY ECG MONITORING ELECTRODE Orbital Research, Inc. | DRX |
| Oct 25, 2006 | K053550 | AMBU BLUE SENSOR NEO AND NEO X Ambu A/S | DRX |
| Oct 25, 2006 | K052944 | AMBU WHITE SENSOR CFM, CFL Ambu A/S | DRX |
| Apr 7, 2006 | K060661 | MACTRODE 3 Ge Medical Systems Information Technologies | DRX |
| Dec 14, 2005 | K053011 | PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 Bio Protech, Inc. | DRX |
| Sep 2, 2005 | K050443 | ACCU-LEAD Kentec Medical, Inc. | DRX |
| May 25, 2005 | K050248 | ELECTRODE Electramold | DRX |
| Mar 22, 2005 | K043361 | ACCUHEART ELECTRODE BELT Advanced Bioelectric Corporation, CA | DRX |
| Dec 22, 2004 | K033559 | 12-LEAD GLOVE Ineedmd | DRX |
| Sep 22, 2004 | K041734 | AMBU DISPOSABLE ECG ELECTRODE Ambu, Inc. | DRX |
| Sep 15, 2004 | K041954 | DISPOSABLE MONITORING ELECTRODES Shanghai Intco Electrode Manufacturing Co., Ltd. | DRX |
| Jun 28, 2004 | K041026 | AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S Ambu, Inc. | DRX |
| Apr 7, 2004 | K040784 | PROTAB ECG TABB ELECTRODE Bio Protech, Inc. | DRX |
| Feb 24, 2004 | K040249 | SKINTACT ECG ELECTRODE Leonhard Lang GmbH | DRX |
| Aug 7, 2003 | K030316 | AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) Inovise Medical, Inc. | DRX |
| Jul 10, 2003 | K031174 | BODY SIGNAL ECG ELECTRODE Wandy Rubber Industrial Co., Ltd., TW | DRX |
| Mar 28, 2003 | K030073 | VERMED A10021 RESTING EKG TAB ELECTRODE Vermont Medical, Inc. | DRX |
| Mar 4, 2003 | K030509 | SKINTACT ECG TAB ELECTRODE Leonhard Lang GmbH | DRX |
| Jan 16, 2003 | K024264 | SKINTACT Leonhard Lang Co. | DRX |
| Jan 16, 2003 | K024247 | SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL Leonhard Lang GmbH | DRX |
| Jan 16, 2003 | K023920 | SKINTACT Leonhard Lang GmbH | DRX |
| Jan 9, 2003 | K022909 | NIKOMED TRACE 1 ECG ELECTRODES Nikomed U.S.A., Inc. | DRX |
| Nov 14, 2002 | K023503 | SKINTACT ECG ELECTRODE Leonhard Lang GmbH | DRX |
| Nov 7, 2002 | K020003 | ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE Bio Protech, Inc. | DRX |
| Jun 28, 2002 | K020382 | BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA Medicotest A/S | DRX |
| Jan 3, 2002 | K011564 | NEOLEAD Neotech Products, Inc. | DRX |
| Aug 30, 2001 | K003804 | SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 Niko Medical Products | DRX |
| Aug 18, 2000 | K002230 | CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 Cambridge Heart, Inc. | DRX |
| Aug 15, 2000 | K993934 | V QUICK PATCH Vq Corp. | DRX |
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