Electrode, Electrocardiograph

FDA product code DRX · 328 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2360
Review panel: CV
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-23 – 2017-08-23

DRX 2017-08-23

Physiotrace

Applicant Nimbleheart, Inc.

K number K171244

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DRX 2013-04-24

BIOMODULE 3-M1

Applicant Zephyr Technology Corporation

K number K123658

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DRX 2010-07-22

CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES

Applicant Team Innovations, Inc.

K number K101576

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DRX 2010-07-01

IP-SET

Applicant Integral Process Sas

K number K101685

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DRX 2010-06-11

AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X

Applicant Ambu A/S

K number K100129

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DRX 2010-05-10

INTCO TAB ELECTRODE

Applicant Shanghai Intco Electrode Manufacturing Co., Ltd.

K number K093327

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DRX 2010-04-23

12 LEAD GLOVE

Applicant I Needmd, Inc.

K number K100315

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DRX 2009-12-10

NEONATAL ECG ELECTRODE, M203KEN

Applicant R & D Medical Products, Inc.

K number K092744

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DRX 2009-10-13

DISPOSAL ECG ELECTRODES, MODEL EASYRODE

Applicant Suzuken Co., Ltd.

K number K092389

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DRX 2009-09-01

QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH

Applicant Cardiac Lead Technologies, Inc.

K number K090496

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DRX 2009-08-21

SKINTACT AND VARIOUS OTHER TRADENAMES

Applicant Leonhard Lang GmbH

K number K092291

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DRX 2009-08-07

CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES

Applicant Conmed Corporation

K number K091856

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DRX 2009-06-17

TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE

Applicant Vermed, Inc.

K number K090180

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DRX 2009-03-10

PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1

Applicant Commwell , Ltd.

K number K083677

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DRX 2008-11-07

TELECTRODE WET GEL ECG ELECTRODE

Applicant Bio Protech, Inc.

K number K083148

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DRX 2008-09-25

AUDICOR SENSOR, MODELS: 2.0, 3.0

Applicant Inovise Medical, Inc.

K number K080602

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DRX 2008-02-01

SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE

Applicant Leonhard Lang GmbH

K number K080106

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DRX 2007-11-16

SKINTACT AND VARIOUS OTHER TRADENAMES

Applicant Leonhard Lang GmbH

K number K073104

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DRX 2007-11-02

TEXTRONICS ECG ELECTRODE

Applicant Textronics, Inc.

K number K071576

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DRX 2007-03-23

CARDIOBELT ELECTRODE BELT

Applicant Monebo Technologies, Inc.

K number K063044

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DRX 2006-12-11

ORI F6T DRY ECG MONITORING ELECTRODE

Applicant Orbital Research, Inc.

K number K062760

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DRX 2006-10-25

AMBU BLUE SENSOR NEO AND NEO X

Applicant Ambu A/S

K number K053550

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DRX 2006-10-25

AMBU WHITE SENSOR CFM, CFL

Applicant Ambu A/S

K number K052944

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DRX 2006-04-07

MACTRODE 3

Applicant Ge Medical Systems Information Technologies

K number K060661

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DRX 2005-12-14

PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20

Applicant Bio Protech, Inc.

K number K053011

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DRX 2005-09-02

ACCU-LEAD

Applicant Kentec Medical, Inc.

K number K050443

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DRX 2005-05-25

ELECTRODE

Applicant Electramold

K number K050248

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DRX 2005-03-22

ACCUHEART ELECTRODE BELT

Applicant Advanced Bioelectric Corporation

K number K043361

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DRX 2004-12-22

12-LEAD GLOVE

Applicant Ineedmd

K number K033559

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DRX 2004-09-22

AMBU DISPOSABLE ECG ELECTRODE

Applicant Ambu, Inc.

K number K041734

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DRX 2004-09-15

DISPOSABLE MONITORING ELECTRODES

Applicant Shanghai Intco Electrode Manufacturing Co., Ltd.

K number K041954

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DRX 2004-06-28

AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S

Applicant Ambu, Inc.

K number K041026

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DRX 2004-04-07

PROTAB ECG TABB ELECTRODE

Applicant Bio Protech, Inc.

K number K040784

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DRX 2004-02-24

SKINTACT ECG ELECTRODE

Applicant Leonhard Lang GmbH

K number K040249

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DRX 2003-08-07

AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)

Applicant Inovise Medical, Inc.

K number K030316

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DRX 2003-07-10

BODY SIGNAL ECG ELECTRODE

Applicant Wandy Rubber Industrial Co., Ltd.

K number K031174

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DRX 2003-03-28

VERMED A10021 RESTING EKG TAB ELECTRODE

Applicant Vermont Medical, Inc.

K number K030073

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DRX 2003-03-04

SKINTACT ECG TAB ELECTRODE

Applicant Leonhard Lang GmbH

K number K030509

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DRX 2003-01-16

SKINTACT

Applicant Leonhard Lang Co.

K number K024264

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DRX 2003-01-16

SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL

Applicant Leonhard Lang GmbH

K number K024247

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DRX 2003-01-16

SKINTACT

Applicant Leonhard Lang GmbH

K number K023920

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DRX 2003-01-09

NIKOMED TRACE 1 ECG ELECTRODES

Applicant Nikomed U.S.A., Inc.

K number K022909

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DRX 2002-11-14

SKINTACT ECG ELECTRODE

Applicant Leonhard Lang GmbH

K number K023503

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DRX 2002-11-07

ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE

Applicant Bio Protech, Inc.

K number K020003

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DRX 2002-06-28

BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA

Applicant Medicotest A/S

K number K020382

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DRX 2002-01-03

NEOLEAD

Applicant Neotech Products, Inc.

K number K011564

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DRX 2001-08-30

SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801

Applicant Niko Medical Products

K number K003804

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DRX 2000-08-18

CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002

Applicant Cambridge Heart, Inc.

K number K002230

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DRX 2000-08-15

V QUICK PATCH

Applicant Vq Corp.

K number K993934

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DRX 2000-05-17

3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE

Applicant Minnesota Mining and Mfg. Co.

K number K000690

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DRX 2000-04-13

PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200

Applicant Axelgaard Mfg. Co., Ltd.

K number K000206

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DRX 1999-12-06

DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440

Applicant Maersk Medical A/S

K number K990115

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DRX 1999-12-06

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560

Applicant Maersk Medical A/S

K number K990113

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DRX 1999-12-06

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610

Applicant Maersk Medical A/S

K number K990112

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DRX 1999-12-06

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570

Applicant Maersk Medical A/S

K number K990111

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DRX 1999-12-06

DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140

Applicant Maersk Medical A/S

K number K990110

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DRX 1999-11-26

ECG ELECTRODE (VARIOUS)

Applicant Conmedcorp

K number K991105

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DRX 1999-10-26

SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES

Applicant Leonhard Lang Co.

K number K982521

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DRX 1999-01-15

BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES

Applicant Medicotest A/S

K number K983689

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DRX 1998-11-13

MEDI-TRACE 4103 NEONATAL ELECTRODE

Applicant Graphic Controls Corp.

K number K981964

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DRX 1998-10-14

ECG ELECTRODES APRON

Applicant Tapuz Medical Technology , Ltd.

K number K982470

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DRX 1998-07-26

3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360

Applicant 3M Healthcare

K number K974445

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DRX 1998-02-10

PALJET-B

Applicant Golden Gate Bio-Device

K number K973663

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DRX 1997-12-19

ELECTRODE, ELECTROCARDIOGRAPH

Applicant Don Tay Industries

K number K973727

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DRX 1997-07-08

NICAS(TM) ELECTRODE

Applicant Ni Medical

K number K972001

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DRX 1997-06-11

3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES

Applicant 3M Medical Products Group

K number K971444

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DRX 1997-04-15

STEALTHSHIELD

Applicant Vital Connections, Inc.

K number K970755

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DRX 1997-04-09

3M RED DOT 2560 & 2570 MONITORING ELECTRODES

Applicant 3M Healthcare

K number K970796

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DRX 1997-03-11

EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM

Applicant Conmedcorp

K number K963787

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DRX 1997-03-04

NOAH MONITORING ELECTRODE SYSTEM

Applicant Contour Medical Technology, Inc.

K number K970125

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DRX 1997-01-07

VERSATEC 310 ELECTRODE

Applicant Versatec, Inc.

K number K963975

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DRX 1996-12-11

CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES

Applicant Cmc Sense-It, Inc.

K number K963159

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DRX 1996-12-09

MEDICOTEST ECG ELECTRODES

Applicant Medicotest, Inc.

K number K961643

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DRX 1996-11-25

TRACE RITE SOLID GEL ECG ELECTRODES

Applicant Bio-Detek, Inc.

K number K964213

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DRX 1996-11-19

MEDI-TRACE 5700 RESTING ECG ELECTRODE

Applicant Graphic Controls Corp.

K number K963151

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DRX 1996-11-15

MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE

Applicant Graphic Controls Corp.

K number K963038

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DRX 1996-10-28

MEDI-TRACE 200, MEDI-TRACE 200-30

Applicant Graphic Controls Corp.

K number K960968

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DRX 1996-08-29

CAMBRIDGE HEART HI-RES ECG ELECTRODE

Applicant Cambridge Heart, Inc.

K number K962115

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DRX 1996-08-08

BODYTRODE

Applicant Marquette Electronics, Inc.

K number K961288

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DRX 1996-07-24

SENTRY RADIOTRANSLUCENT ECG ELECTRODES

Applicant Sentry Medical Products, Inc.

K number K962122

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DRX 1996-07-23

G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE

Applicant Cmc Sense-It, Inc.

K number K955815

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DRX 1996-07-18

PACEART WRIST ELECTRODES

Applicant Paceart, Inc.

K number K960721

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DRX 1996-07-11

QUICKELS QS 100 SYSTEM

Applicant Ferguson Medical

K number K954773

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DRX 1996-07-11

QUICKELS QS 200 SYSTEM

Applicant Ferguson Medical

K number K954772

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DRX 1996-06-21

DISPOSABLE ECG ELECTRODE

Applicant Kendall-Ltp

K number K953649

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DRX 1996-06-07

MEDI-TRACE RADIOLUCENT

Applicant Graphic Controls Corp.

K number K961395

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DRX 1996-05-17

SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE

Applicant Cmc Sense-It, Inc.

K number K955800

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DRX 1996-05-17

UNILECT, MONITAB AND BIOTRACE-HR

Applicant Msb , Ltd.

K number K944497

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DRX 1996-05-16

CONMED ECG/EKG ELECTRODES

Applicant Conmedcorp

K number K954389

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DRX 1996-05-16

BIOTRACE-N, NS, 410 AND RT

Applicant Msb , Ltd.

K number K944496

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DRX 1996-04-09

CONMED EKG STRIPPER

Applicant Conmedcorp

K number K960264

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DRX 1996-02-06

CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE

Applicant Conmedcorp

K number K954388

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DRX 1995-12-12

DISPOSABLE ECG MONITORING ELECTRODE

Applicant Nikomed U.S.A., Inc.

K number K950473

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DRX 1995-11-14

DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540

Applicant Nikomed U.S.A., Inc.

K number K950475

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DRX 1995-11-14

DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM

Applicant Nikomed U.S.A., Inc.

K number K950472

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DRX 1995-11-06

DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM

Applicant Nikomed U.S.A., Inc.

K number K950480

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DRX 1995-11-06

DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM

Applicant Nikomed U.S.A., Inc.

K number K950478

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DRX 1995-11-06

DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM

Applicant Nikomed U.S.A., Inc.

K number K950477

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DRX 1995-11-06

DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM

Applicant Nikomed U.S.A., Inc.

K number K950474

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DRX 1995-11-06

DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM

Applicant Nikomed U.S.A., Inc.

K number K950471

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