FDA Product Code
FDA Product Code DRX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2360
510(k) Clearances — 329 records · page 1 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K171244 | Physiotrace | Nimbleheart, Inc. | 2017-08-23 | Traditional | PDF ↗ |
| K140096 | HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE | Hmicro, Inc. | 2014-07-24 | Traditional | PDF ↗ |
| K123658 | BIOMODULE 3-M1 | Zephyr Technology Corporation | 2013-04-24 | Traditional | PDF ↗ |
| K101576 | CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES | Team Innovations, Inc. | 2010-07-22 | Traditional | PDF ↗ |
| K101685 | IP-SET | Integral Process Sas | 2010-07-01 | Traditional | PDF ↗ |
| K100129 | AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X | Ambu A/S | 2010-06-11 | Abbreviated | PDF ↗ |
| K093327 | INTCO TAB ELECTRODE | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2010-05-10 | Abbreviated | PDF ↗ |
| K100315 | 12 LEAD GLOVE | I Needmd, Inc. | 2010-04-23 | Special | PDF ↗ |
| K092744 | NEONATAL ECG ELECTRODE, M203KEN | R & D Medical Products, Inc. | 2009-12-10 | Traditional | PDF ↗ |
| K092389 | DISPOSAL ECG ELECTRODES, MODEL EASYRODE | Suzuken Co., Ltd. | 2009-10-13 | Traditional | PDF ↗ |
| K090496 | QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH | Cardiac Lead Technologies, Inc. | 2009-09-01 | Traditional | PDF ↗ |
| K092291 | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | 2009-08-21 | Special | PDF ↗ |
| K091856 | CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES | Conmed Corporation | 2009-08-07 | Special | PDF ↗ |
| K090180 | TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE | Vermed, Inc. | 2009-06-17 | Abbreviated | PDF ↗ |
| K083677 | PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 | Commwell , Ltd. | 2009-03-10 | Traditional | PDF ↗ |
| K083148 | TELECTRODE WET GEL ECG ELECTRODE | Bio Protech, Inc. | 2008-11-07 | Traditional | PDF ↗ |
| K080602 | AUDICOR SENSOR, MODELS: 2.0, 3.0 | Inovise Medical, Inc. | 2008-09-25 | Traditional | PDF ↗ |
| K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | Leonhard Lang GmbH | 2008-02-01 | Special | PDF ↗ |
| K073104 | SKINTACT AND VARIOUS OTHER TRADENAMES | Leonhard Lang GmbH | 2007-11-16 | Special | PDF ↗ |
| K071576 | TEXTRONICS ECG ELECTRODE | Textronics, Inc. | 2007-11-02 | Traditional | PDF ↗ |
| K063044 | CARDIOBELT ELECTRODE BELT | Monebo Technologies, Inc. | 2007-03-23 | Abbreviated | PDF ↗ |
| K062760 | ORI F6T DRY ECG MONITORING ELECTRODE | Orbital Research, Inc. | 2006-12-11 | Traditional | PDF ↗ |
| K053550 | AMBU BLUE SENSOR NEO AND NEO X | Ambu A/S | 2006-10-25 | Traditional | PDF ↗ |
| K052944 | AMBU WHITE SENSOR CFM, CFL | Ambu A/S | 2006-10-25 | Traditional | PDF ↗ |
| K060661 | MACTRODE 3 | Ge Medical Systems Information Technologies | 2006-04-07 | Special | PDF ↗ |
| K053011 | PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 | Bio Protech, Inc. | 2005-12-14 | Traditional | PDF ↗ |
| K050443 | ACCU-LEAD | Kentec Medical, Inc. | 2005-09-02 | Traditional | PDF ↗ |
| K050248 | ELECTRODE | Electramold | 2005-05-25 | Traditional | PDF ↗ |
| K043361 | ACCUHEART ELECTRODE BELT | Advanced Bioelectric Corporation | 2005-03-22 | Traditional | PDF ↗ |
| K033559 | 12-LEAD GLOVE | Ineedmd | 2004-12-22 | Traditional | PDF ↗ |
| K041734 | AMBU DISPOSABLE ECG ELECTRODE | Ambu, Inc. | 2004-09-22 | Traditional | PDF ↗ |
| K041954 | DISPOSABLE MONITORING ELECTRODES | Shanghai Intco Electrode Manufacturing Co., Ltd. | 2004-09-15 | Traditional | PDF ↗ |
| K041026 | AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S | Ambu, Inc. | 2004-06-28 | Traditional | PDF ↗ |
| K040784 | PROTAB ECG TABB ELECTRODE | Bio Protech, Inc. | 2004-04-07 | Traditional | PDF ↗ |
| K040249 | SKINTACT ECG ELECTRODE | Leonhard Lang GmbH | 2004-02-24 | Special | PDF ↗ |
| K030316 | AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) | Inovise Medical, Inc. | 2003-08-07 | Traditional | PDF ↗ |
| K031174 | BODY SIGNAL ECG ELECTRODE | Wandy Rubber Industrial Co., Ltd. | 2003-07-10 | Traditional | PDF ↗ |
| K030073 | VERMED A10021 RESTING EKG TAB ELECTRODE | Vermont Medical, Inc. | 2003-03-28 | Special | PDF ↗ |
| K030509 | SKINTACT ECG TAB ELECTRODE | Leonhard Lang GmbH | 2003-03-04 | Special | PDF ↗ |
| K024264 | SKINTACT | Leonhard Lang Co. | 2003-01-16 | Special | PDF ↗ |
| K023920 | SKINTACT | Leonhard Lang GmbH | 2003-01-16 | Traditional | PDF ↗ |
| K024247 | SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL | Leonhard Lang GmbH | 2003-01-16 | Special | PDF ↗ |
| K022909 | NIKOMED TRACE 1 ECG ELECTRODES | Nikomed U.S.A., Inc. | 2003-01-09 | Special | PDF ↗ |
| K023503 | SKINTACT ECG ELECTRODE | Leonhard Lang GmbH | 2002-11-14 | Special | PDF ↗ |
| K020003 | ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE | Bio Protech, Inc. | 2002-11-07 | Traditional | PDF ↗ |
| K020382 | BLUE SENSOR, DISPOSABLE ECG ELECTRODES FOR ANAESTHESIA | Medicotest A/S | 2002-06-28 | Traditional | PDF ↗ |
| K011564 | NEOLEAD | Neotech Products, Inc. | 2002-01-03 | Traditional | PDF ↗ |
| K003804 | SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 | Niko Medical Products | 2001-08-30 | Abbreviated | PDF ↗ |
| K002230 | CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 | Cambridge Heart, Inc. | 2000-08-18 | Special | PDF ↗ |
| K993934 | V QUICK PATCH | Vq Corp. | 2000-08-15 | Traditional | PDF ↗ |
| K000690 | 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE | Minnesota Mining and Mfg. Co. | 2000-05-17 | Traditional | PDF ↗ |
| K000206 | PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 | Axelgaard Mfg. Co., Ltd. | 2000-04-13 | Traditional | PDF ↗ |
| K990110 | DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 | Maersk Medical A/S | 1999-12-06 | Traditional | PDF ↗ |
| K990112 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 | Maersk Medical A/S | 1999-12-06 | Traditional | PDF ↗ |
| K990111 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 | Maersk Medical A/S | 1999-12-06 | Traditional | PDF ↗ |
| K990113 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 | Maersk Medical A/S | 1999-12-06 | Traditional | PDF ↗ |
| K990115 | DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 | Maersk Medical A/S | 1999-12-06 | Traditional | PDF ↗ |
| K991105 | ECG ELECTRODE (VARIOUS) | Conmedcorp | 1999-11-26 | Traditional | PDF ↗ |
| K982521 | SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES | Leonhard Lang Co. | 1999-10-26 | Traditional | PDF ↗ |
| K983689 | BLUE SENSOR SUPATAB,DISPOSABLE ECG ELECTRODES | Medicotest A/S | 1999-01-15 | Traditional | PDF ↗ |
| K981964 | MEDI-TRACE 4103 NEONATAL ELECTRODE | Graphic Controls Corp. | 1998-11-13 | Traditional | PDF ↗ |
| K982470 | ECG ELECTRODES APRON | Tapuz Medical Technology , Ltd. | 1998-10-14 | Traditional | PDF ↗ |
| K974445 | 3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360 | 3M Healthcare | 1998-07-26 | Traditional | PDF ↗ |
| K973663 | PALJET-B | Golden Gate Bio-Device | 1998-02-10 | Traditional | PDF ↗ |
| K973727 | ELECTRODE, ELECTROCARDIOGRAPH | Don Tay Industries | 1997-12-19 | Traditional | PDF ↗ |
| K972001 | NICAS(TM) ELECTRODE | Ni Medical | 1997-07-08 | Traditional | PDF ↗ |
| K971444 | 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES | 3M Medical Products Group | 1997-06-11 | Traditional | PDF ↗ |
| K970755 | STEALTHSHIELD | Vital Connections, Inc. | 1997-04-15 | Traditional | PDF ↗ |
| K970796 | 3M RED DOT 2560 & 2570 MONITORING ELECTRODES | 3M Healthcare | 1997-04-09 | Traditional | PDF ↗ |
| K963787 | EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM | Conmedcorp | 1997-03-11 | Traditional | PDF ↗ |
| K970125 | NOAH MONITORING ELECTRODE SYSTEM | Contour Medical Technology, Inc. | 1997-03-04 | Traditional | PDF ↗ |
| K963975 | VERSATEC 310 ELECTRODE | Versatec, Inc. | 1997-01-07 | Traditional | PDF ↗ |
| K963159 | CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES | Cmc Sense-It, Inc. | 1996-12-11 | Traditional | PDF ↗ |
| K961643 | MEDICOTEST ECG ELECTRODES | Medicotest, Inc. | 1996-12-09 | Traditional | PDF ↗ |
| K964213 | TRACE RITE SOLID GEL ECG ELECTRODES | Bio-Detek, Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K963151 | MEDI-TRACE 5700 RESTING ECG ELECTRODE | Graphic Controls Corp. | 1996-11-19 | Traditional | PDF ↗ |
| K963038 | MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE | Graphic Controls Corp. | 1996-11-15 | Traditional | PDF ↗ |
| K960968 | MEDI-TRACE 200, MEDI-TRACE 200-30 | Graphic Controls Corp. | 1996-10-28 | Traditional | PDF ↗ |
| K962115 | CAMBRIDGE HEART HI-RES ECG ELECTRODE | Cambridge Heart, Inc. | 1996-08-29 | Traditional | PDF ↗ |
| K961288 | BODYTRODE | Marquette Electronics, Inc. | 1996-08-08 | Traditional | PDF ↗ |
| K962122 | SENTRY RADIOTRANSLUCENT ECG ELECTRODES | Sentry Medical Products, Inc. | 1996-07-24 | Traditional | PDF ↗ |
| K955815 | G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE | Cmc Sense-It, Inc. | 1996-07-23 | Traditional | PDF ↗ |
| K960721 | PACEART WRIST ELECTRODES | Paceart, Inc. | 1996-07-18 | Traditional | PDF ↗ |
| K954772 | QUICKELS QS 200 SYSTEM | Ferguson Medical | 1996-07-11 | Traditional | PDF ↗ |
| K954773 | QUICKELS QS 100 SYSTEM | Ferguson Medical | 1996-07-11 | Traditional | PDF ↗ |
| K953649 | DISPOSABLE ECG ELECTRODE | Kendall-Ltp | 1996-06-21 | Traditional | PDF ↗ |
| K961395 | MEDI-TRACE RADIOLUCENT | Graphic Controls Corp. | 1996-06-07 | Traditional | PDF ↗ |
| K955800 | SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELECTRODE | Cmc Sense-It, Inc. | 1996-05-17 | Traditional | PDF ↗ |
| K944497 | UNILECT, MONITAB AND BIOTRACE-HR | Msb , Ltd. | 1996-05-17 | Traditional | PDF ↗ |
| K944496 | BIOTRACE-N, NS, 410 AND RT | Msb , Ltd. | 1996-05-16 | Traditional | PDF ↗ |
| K954389 | CONMED ECG/EKG ELECTRODES | Conmedcorp | 1996-05-16 | Traditional | PDF ↗ |
| K960264 | CONMED EKG STRIPPER | Conmedcorp | 1996-04-09 | Traditional | PDF ↗ |
| K954388 | CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE | Conmedcorp | 1996-02-06 | Traditional | PDF ↗ |
| K950473 | DISPOSABLE ECG MONITORING ELECTRODE | Nikomed U.S.A., Inc. | 1995-12-12 | Traditional | PDF ↗ |
| K950475 | DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540 | Nikomed U.S.A., Inc. | 1995-11-14 | Traditional | PDF ↗ |
| K950472 | DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM | Nikomed U.S.A., Inc. | 1995-11-14 | Traditional | PDF ↗ |
| K950477 | DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM | Nikomed U.S.A., Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K950470 | DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM | Nikomed U.S.A., Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K950474 | DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM | Nikomed U.S.A., Inc. | 1995-11-06 | Traditional | PDF ↗ |
| K950471 | DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM | Nikomed U.S.A., Inc. | 1995-11-06 | Traditional | PDF ↗ |
Product code DRX · Class II · Cardiovascular. Data: openFDA.