Electrode, Electrocardiograph
FDA product code DRX · Class II (moderate risk) · 21 CFR 870.2360 · Cardiovascular
329510(k) clearances
0PMA approvals
18recalls
Manufacturers
- Graphic Controls Corp. 17
- Nikomed U.S.A., Inc. 12
- Lectec Corp. 11
- Labeltape Meditect, Inc. 10
- Leonhard Lang GmbH 10
- Andover Medical, Inc. 8
- Arbo Medical, Inc. 7
- S & W Medico Teknik 7
- Conmed Andover Medical, Inc. 6
- Conmedcorp 6
- Medtronic Vascular 6
- Electromed Intl., Ltd. 6
- Tdk Corp. 5
- Jason Marketing Co. 5
- Hewlett-Packard Co. 5
- Medicotest, Inc. 5
- Marquette Electronics, Inc. 5
- Vermont Medical, Inc. 5
- C.R. Bard, Inc. 5
- Physio-Control Corp. 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171244 | PhysiotraceDRX · Traditional | Nimbleheart, Inc. | 08/23/2017SE |
| K140096 | Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeDRX · Traditional | Hmicro, Inc. | 07/24/2014SE |
| K123658 | Biomodule 3-M1DRX · Traditional | Zephyr Technology Corporation | 04/24/2013SE |
| K101576 | Centerridge Diagnostic ECG Electrode, Centerridge Monitoring ECG ElectrodesDRX · Traditional | Team Innovations, Inc. | 07/22/2010SE |
| K101685 | Ip-SetDRX · Traditional | Integral Process Sas | 07/01/2010SE |
| K100129 | Ambu Blue Sensor Neo, Ambu Blue Sensor Neo XDRX · Abbreviated | Ambu A/S | 06/11/2010SE |
| K093327 | Intco Tab ElectrodeDRX · Abbreviated | Shanghai Intco Electrode Manufacturing Co., Ltd. | 05/10/2010SE |
| K100315 | 12 Lead GloveDRX · Special | I Needmd, Inc. | 04/23/2010SE |
| K092744 | Neonatal ECG Electrode, M203KENDRX · Traditional | R & D Medical Products, Inc. | 12/10/2009SE |
| K092389 | Disposal ECG Electrodes, Model EasyrodeDRX · Traditional | Suzuken Co., Ltd. | 10/13/2009SE |
| K090496 | Qwiklead Reusable Electrocardiograph Electrode PatchDRX · Traditional | Cardiac Lead Technologies, Inc. | 09/01/2009SE |
| K092291 | Skintact and Various Other TradenamesDRX · Special | Leonhard Lang GmbH | 08/21/2009SE |
| K091856 | Conmed ECG Monitoring Electrodes , Model 1700 ( Including 2500), 1750, 2700, 2710, 1800…DRX · Special | Conmed Corporation | 08/07/2009SE |
| K090180 | Tender-Trode Prewired Pediatric ECG ElectrodeDRX · Abbreviated | Vermed, Inc. | 06/17/2009SE |
| K083677 | Physioglove for Use with Physioglove ES1DRX · Traditional | Commwell , Ltd. | 03/10/2009SE |
| K083148 | Telectrode Wet Gel ECG ElectrodeDRX · Traditional | Bio Protech, Inc. | 11/07/2008SE |
| K080602 | Audicor Sensor, Models: 2.0, 3.0DRX · Traditional | Inovise Medical, Inc. | 09/25/2008SE |
| K080106 | Skintact Pre-Wired ECG Electrodes with Conductive AdhesiveDRX · Special | Leonhard Lang GmbH | 02/01/2008SE |
| K073104 | Skintact and Various Other TradenamesDRX · Special | Leonhard Lang GmbH | 11/16/2007SE |
| K071576 | Textronics ECG ElectrodeDRX · Traditional | Textronics, Inc. | 11/02/2007SE |
| K063044 | Cardiobelt Electrode BeltDRX · Abbreviated | Monebo Technologies, Inc. | 03/23/2007SE |
| K062760 | Ori F6T Dry ECG Monitoring ElectrodeDRX · Traditional | Orbital Research, Inc. | 12/11/2006SE |
| K053550 | Ambu Blue Sensor Neo and Neo XDRX · Traditional | Ambu A/S | 10/25/2006SE |
| K052944 | Ambu White Sensor CFM, CFLDRX · Traditional | Ambu A/S | 10/25/2006SE |
| K060661 | Mactrode 3DRX · Special | Ge Medical Systems Information Technologies | 04/07/2006SE |
| K053011 | Pro-Neo Neonatal ECG Electrode, Models SG15 and SR20DRX · Traditional | Bio Protech, Inc. | 12/14/2005SE |
| K050443 | Accu-LeadDRX · Traditional | Kentec Medical, Inc. | 09/02/2005SE |
| K050248 | ElectrodeDRX · Traditional | Electramold | 05/25/2005SE |
| K043361 | Accuheart Electrode BeltDRX · Traditional | Advanced Bioelectric Corporation | 03/22/2005SE |
| K033559 | 12-LEAD GloveDRX · Traditional | Ineedmd | 12/22/2004SE |
| K041734 | Ambu Disposable ECG ElectrodeDRX · Traditional | Ambu, Inc. | 09/22/2004SE |
| K041954 | Disposable Monitoring ElectrodesDRX · Traditional | Shanghai Intco Electrode Manufacturing Co., Ltd. | 09/15/2004SE |
| K041026 | Ambu Blue Sensor, MRX, ECG Electrode Product #:MRX-00-SDRX · Traditional | Ambu, Inc. | 06/28/2004SE |
| K040784 | Protab ECG Tabb ElectrodeDRX · Traditional | Bio Protech, Inc. | 04/07/2004SE |
| K040249 | Skintact ECG ElectrodeDRX · Special | Leonhard Lang GmbH | 02/24/2004SE |
| K030316 | Audicor Cor Sensor (and Accessory Adaptor)DRX · Traditional | Inovise Medical, Inc. | 08/07/2003SE |
| K031174 | Body Signal ECG ElectrodeDRX · Traditional | Wandy Rubber Industrial Co., Ltd. | 07/10/2003SE |
| K030073 | Vermed A10021 Resting EKG Tab ElectrodeDRX · Special | Vermont Medical, Inc. | 03/28/2003SE |
| K030509 | Skintact ECG Tab ElectrodeDRX · Special | Leonhard Lang GmbH | 03/04/2003SE |
| K024264 | SkintactDRX · Special | Leonhard Lang Co. | 01/16/2003SE |
| K024247 | Skintact ECG Electrodes with KL 02 Liquid GelDRX · Special | Leonhard Lang GmbH | 01/16/2003SE |
| K023920 | SkintactDRX · Traditional | Leonhard Lang GmbH | 01/16/2003SE |
| K022909 | Nikomed Trace 1 ECG ElectrodesDRX · Special | Nikomed U.S.A., Inc. | 01/09/2003SE |
| K023503 | Skintact ECG ElectrodeDRX · Special | Leonhard Lang GmbH | 11/14/2002SE |
| K020003 | Electrocardiograph (ECG) Electrode, Non-SterileDRX · Traditional | Bio Protech, Inc. | 11/07/2002SE |
| K020382 | Blue Sensor, Disposable ECG Electrodes for AnaesthesiaDRX · Traditional | Medicotest A/S | 06/28/2002SE |
| K011564 | NeoleadDRX · Traditional | Neotech Products, Inc. | 01/03/2002SE |
| K003804 | Sensi-Prema Neonatal ECG Electrodes, 40612,40614,40626,40550,40554,40555,440556,40610,406…DRX · Abbreviated | Niko Medical Products | 08/30/2001SE |
| K002230 | Cambridge Heart Micro-V Alternans Sensor, Model 20327-002DRX · Special | Cambridge Heart, Inc. | 08/18/2000SE |
| K993934 | V Quick PatchDRX · Traditional | Vq Corp. | 08/15/2000SE |
| K000690 | 3M Red Dot Radiolucent Monitoring Electrode with Conductive AdhesiveDRX · Traditional | Minnesota Mining and Mfg. Co. | 05/17/2000SE |
| K000206 | Pals Neonatal Pediatric ECG Electrode, Models PN100, PN200DRX · Traditional | Axelgaard Mfg. Co., Ltd. | 04/13/2000SE |
| K990115 | Disposable ECG Monitoring Electrodes, Models, 4420, 4440DRX · Traditional | Maersk Medical A/S | 12/06/1999SE |
| K990113 | Disposable ECG Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560DRX · Traditional | Maersk Medical A/S | 12/06/1999SE |
| K990112 | Disposable ECG Monitoring Electrodes, Models 4060, 4610DRX · Traditional | Maersk Medical A/S | 12/06/1999SE |
| K990111 | Disposable ECG Monitoring Electrodes, Models 4520, 4535, 4570DRX · Traditional | Maersk Medical A/S | 12/06/1999SE |
| K990110 | Disposable ECG Monitoring Electrodes, Model 4110, 4140DRX · Traditional | Maersk Medical A/S | 12/06/1999SE |
| K991105 | ECG Electrode (Various)DRX · Traditional | Conmedcorp | 11/26/1999SE |
| K982521 | Skintact ECG Electrodes, S&W ECG ElectrodesDRX · Traditional | Leonhard Lang Co. | 10/26/1999SE |
| K983689 | Blue Sensor Supatab,Disposable ECG ElectrodesDRX · Traditional | Medicotest A/S | 01/15/1999SE |
| K981964 | Medi-Trace 4103 Neonatal ElectrodeDRX · Traditional | Graphic Controls Corp. | 11/13/1998SE |
| K982470 | ECG Electrodes ApronDRX · Traditional | Tapuz Medical Technology , Ltd. | 10/14/1998SE |
| K974445 | 3M Red Dot Resting EKG Electrode, Catalog 2360DRX · Traditional | 3M Healthcare | 07/26/1998SE |
| K973663 | Paljet-BDRX · Traditional | Golden Gate Bio-Device | 02/10/1998SE |
| K973727 | Electrode, ElectrocardiographDRX · Traditional | Don Tay Industries | 12/19/1997SE |
| K972001 | Nicas(Tm) ElectrodeDRX · Traditional | Ni Medical | 07/08/1997SE |
| K971444 | 3M Red Dot 2234 & 2266 Radiolucent Monitoring ElectrodesDRX · Traditional | 3M Medical Products Group | 06/11/1997SE |
| K970755 | StealthshieldDRX · Traditional | Vital Connections, Inc. | 04/15/1997SE |
| K970796 | 3M Red Dot 2560 & 2570 Monitoring ElectrodesDRX · Traditional | 3M Healthcare | 04/09/1997SE |
| K963787 | Exactrace Adult Foam Monitoring ECG Electrode Conmed Model 1510 and Instatrace Adult…DRX · Traditional | Conmedcorp | 03/11/1997SE |
| K970125 | Noah Monitoring Electrode SystemDRX · Traditional | Contour Medical Technology, Inc. | 03/04/1997SE |
| K963975 | Versatec 310 ElectrodeDRX · Traditional | Versatec, Inc. | 01/07/1997SE |
| K963159 | Conductive Hydrogel Polymer Based on U & C Series ElectrodesDRX · Traditional | Cmc Sense-It, Inc. | 12/11/1996SE |
| K961643 | Medicotest ECG ElectrodesDRX · Traditional | Medicotest, Inc. | 12/09/1996SE |
| K964213 | Trace Rite Solid Gel ECG ElectrodesDRX · Traditional | Bio-Detek, Inc. | 11/25/1996SE |
| K963151 | Medi-Trace 5700 Resting ECG ElectrodeDRX · Traditional | Graphic Controls Corp. | 11/19/1996SE |
| K963038 | Medi-Trace 3600 Series of ECG Monitoring ElectrodeDRX · Traditional | Graphic Controls Corp. | 11/15/1996SE |
| K960968 | Medi-Trace 200, Medi-Trace 200-30DRX · Traditional | Graphic Controls Corp. | 10/28/1996SE |
| K962115 | Cambridge Heart Hi-Res ECG ElectrodeDRX · Traditional | Cambridge Heart, Inc. | 08/29/1996SE |
| K961288 | BodytrodeDRX · Traditional | Marquette Electronics, Inc. | 08/08/1996SE |
| K962122 | Sentry Radiotranslucent ECG ElectrodesDRX · Traditional | Sentry Medical Products, Inc. | 07/24/1996SE |
| K955815 | G3000 or AG2000; Disposable Resting ElectrodeDRX · Traditional | Cmc Sense-It, Inc. | 07/23/1996SE |
| K960721 | Paceart Wrist ElectrodesDRX · Traditional | Paceart, Inc. | 07/18/1996SE |
| K954773 | Quickels QS 100 SystemDRX · Traditional | Ferguson Medical | 07/11/1996SE |
| K954772 | Quickels QS 200 SystemDRX · Traditional | Ferguson Medical | 07/11/1996SE |
| K953649 | Disposable ECG ElectrodeDRX · Traditional | Kendall-Ltp | 06/21/1996SE |
| K961395 | Medi-Trace RadiolucentDRX · Traditional | Graphic Controls Corp. | 06/07/1996SE |
| K955800 | SI2000 (Sense-It Trademark) or G2000; Disposable Resting ElectrodeDRX · Traditional | Cmc Sense-It, Inc. | 05/17/1996SE |
| K944497 | Unilect, Monitab and Biotrace-HrDRX · Traditional | Msb , Ltd. | 05/17/1996SE |
| K954389 | Conmed Ecg/Ekg ElectrodesDRX · Traditional | Conmedcorp | 05/16/1996SE |
| K944496 | Biotrace-N, NS, 410 and RTDRX · Traditional | Msb , Ltd. | 05/16/1996SE |
| K960264 | Conmed EKG StripperDRX · Traditional | Conmedcorp | 04/09/1996SE |
| K954388 | Conmed 2710 Cleartrace 2 LT Monitoring ECG ElectrodeDRX · Traditional | Conmedcorp | 02/06/1996SE |
| K950473 | Disposable ECG Monitoring ElectrodeDRX · Traditional | Nikomed U.S.A., Inc. | 12/12/1995SE |
| K950475 | Disposable ECG Monitoring Electrode #4530, #4540DRX · Traditional | Nikomed U.S.A., Inc. | 11/14/1995SE |
| K950472 | Disposable ECG Monitoring Electrode #4110 45MM, #4140 35MMDRX · Traditional | Nikomed U.S.A., Inc. | 11/14/1995SE |
| K950480 | Disposable ECG Monitoring Electrode #4539 28X45MMDRX · Traditional | Nikomed U.S.A., Inc. | 11/06/1995SE |
| K950478 | Disposable ECG Monitoring Electrode #4570 38X60MMDRX · Traditional | Nikomed U.S.A., Inc. | 11/06/1995SE |
| K950477 | Disposable ECG Monitoring Electrode #4560 38X60MMDRX · Traditional | Nikomed U.S.A., Inc. | 11/06/1995SE |
| K950474 | Disposable ECG Monitoring Electrode #4533 32X45MMDRX · Traditional | Nikomed U.S.A., Inc. | 11/06/1995SE |
| K950471 | Disposable ECG Monitoring Electrode #4580 32X45MMDRX · Traditional | Nikomed U.S.A., Inc. | 11/06/1995SE |
| K950470 | Disposable ECG Monitoring Electrode #4535 32X45MMDRX · Traditional | Nikomed U.S.A., Inc. | 11/06/1995SE |
| K950587 | EcotabsDRX · Traditional | Msb , Ltd. | 10/16/1995SE |
| K950479 | Disposable ECG Monitoring Electrode #4600 60MM, #4610 45MMDRX · Traditional | Nikomed U.S.A., Inc. | 09/13/1995SE |
| K950476 | Disposable ECG Monitoring Electrode #4440 60MM, #4420 40MMDRX · Traditional | Nikomed U.S.A., Inc. | 09/06/1995SE |
| K950485 | Graphic Controls Protrace ECG ElectrodeDRX · Traditional | Graphic Controls Corp. | 07/07/1995SE |
| K945479 | Medi-Trace(R) 500 ECG ElectrodeDRX · Traditional | Graphic Controls Corp. | 07/07/1995SE |
| K944260 | ECG ElectrodeDRX · Traditional | Msb , Ltd. | 07/07/1995SE |
| K950489 | Graphic Controls Biotac Jr. ECG ElectrodeDRX · Traditional | Graphic Controls Corp. | 07/03/1995SE |
| K950488 | Graphic Controls Biotac Eco ElectrodeDRX · Traditional | Graphic Controls Corp. | 07/03/1995SE |
| K945836 | 1800 Monitoring ECG Electrode and 1870 Diaphoretic Monitoring ECG ElectrodesDRX · Traditional | Conmed Andover Medical, Inc. | 06/20/1995SE |
| K950487 | Graphic Controls Q-Trace Gold ECG ElectrodeDRX · Traditional | Graphic Controls Corp. | 05/17/1995SE |
| K950486 | Graphic Controls Q-Trace ECG ElectrodeDRX · Traditional | Graphic Controls Corp. | 05/17/1995SE |
| K946273 | 1700 Monitoring ECG ElectrodeDRX · Traditional | Conmed Andover Medical, Inc. | 05/17/1995SE |
| K935437 | Arbo H85V/H87V/H27V Dispos Monit ElectrodesDRX · Traditional | Arbo Medical, Inc. | 04/06/1995SE |
| K932903 | EKG VestDRX · Traditional | Cardiotronics, Inc. | 02/24/1995SE |
| K943301 | Quik ComboDRX · Traditional | Physio-Control Corp. | 02/03/1995SE |
| K935371 | R2 Pads, R2 Cath Pads, R2 Pace Pads, R2 Dispersive PadDRX · Traditional | R2 Medical Systems | 12/02/1994SE |
| K944726 | 1710 Monitoring ECG ElectrodeDRX · Traditional | Conmed Andover Medical, Inc. | 11/22/1994SE |
| K944655 | ECG ElectrodeDRX · Traditional | Conmed Andover Medical, Inc. | 11/22/1994SE |
| K934505 | Trigel Multifunction ElectrodeDRX · Traditional | Physiometrix, Inc. | 11/22/1994SE |
| K935246 | Arbo H49P, H59P Disposable Monitoring ElectrodesDRX · Traditional | Arbo Medical, Inc. | 11/16/1994SE |
| K945214 | Medi-Trace Neonatal ECG Electrode with Preattached LeadwireDRX · Traditional | Graphic Controls Corp. | 11/10/1994SE |
| K935429 | Arbo H90, H91, H135 Disposable Monitoring ElectrodesDRX · Traditional | Arbo Medical, Inc. | 11/01/1994SE |
| K944849 | 2700 Cleartrace Radiotranslucent Monitoring ECG ElectrobeDRX · Traditional | Conmed Andover Medical, Inc. | 10/17/1994SE |
| K941977 | Taylor Long Term Monitoring ElectrodeDRX · Traditional | Taylor Industries, Inc. | 09/21/1994SE |
| K935281 | Arbo H87P, H85P, H27P Disposable Monitoring ElectrodesDRX · Traditional | Arbo Medical, Inc. | 09/06/1994SE |
| K934000 | Sentry Aqueous Gel ECG ElectrodesDRX · Traditional | Sentry Medical Products, Inc. | 08/30/1994SE |
| K940801 | K-KlipDRX · Traditional | Katecho, Inc. | 08/03/1994SE |
| K942925 | Conmed Andover Med ECG ElectrodesDRX · Traditional | Conmed Andover Medical, Inc. | 07/20/1994SE |
| K934333 | 3M Red Dot 2237 Sticky Gel Monitoring ECG ElectrodeDRX · Traditional | 3M Medical Products Group | 07/07/1994SE |
| K940802 | Zipprep ElectrodeDRX · Traditional | Aspect Medical Systems, Inc. | 06/22/1994SE |
| K940586 | K-SnapDRX · Traditional | Katecho, Inc. | 06/09/1994SE |
| K931457 | NDM Silvon ECG ElectrodesDRX · Traditional | Ndm Acquisition Corp. | 11/23/1993SE |
| K931903 | Surelock(Tm) Snapless Monitoring ElectrodeDRX · Traditional | Ludlow Technical Products | 10/07/1993SE |
| K930312 | 3M Red Dot 2234 Radiolucent Monitoring ElectrodeDRX · Traditional | 3M Health Care, Ltd. | 09/01/1993SE |
| K932454 | 3M Red Dot 2330 Resting EKG ElectrodeDRX · Traditional | 3M Health Care, Ltd. | 08/16/1993SE |
| K930258 | Tracet T-6000DRX · Traditional | Lectec Corp. | 04/16/1993SE |
| K921164 | Model 1300 Softrace II ElectrodeDRX · Traditional | Medtronic Vascular | 03/18/1993SE |
| K923558 | ECG ElectrodeDRX · Traditional | Lectec Corp. | 02/18/1993SE |
| K911529 | Bunny Electrode/Stealth Electrode Pre Wired EEGDRX · Traditional | Lead-Lok, Inc. | 11/09/1992SE |
| K911518 | Bunny Electrode/Stealth Solid Gel-Snap on FoamDRX · Traditional | Lead-Lok, Inc. | 11/09/1992SE |
| K924133 | Electrotrace, ModificationDRX · Traditional | Jason Marketing Co. | 10/30/1992SE |
| K921207 | Drigel Defibrillator/Synchronized CoardioversionDRX · Traditional | Physiometrix, Inc. | 10/13/1992SE |
| K921579 | BR-50-J Disposable ECG ElectrodeDRX · Traditional | Medicotest, Inc. | 05/26/1992SE |
| K920867 | Eme MP3000 Monitoring and Diagnostic Resting ECGDRX · Traditional | Electro Medical Equipment Co., Inc. | 04/10/1992SE |
| K914672 | QR-50-E Disposable Radiotranslucent ECG ElectrodeDRX · Traditional | Medicotest, Inc. | 10/31/1991SE |
| K911687 | Ver-Med A10020 Resting EKG ElectrodeDRX · Traditional | Vermont Medical, Inc. | 10/10/1991SE |
| K911472 | Bio-Sensor 01 EKG ElectrodeDRX · Traditional | Bio-Sensor, Inc. | 10/10/1991SE |
| K913226 | Model #810 Stealth-Stim Adult Stimulation PadsDRX · Traditional | Cardiotronics, Inc. | 09/04/1991SE |
| K912450 | Tracets Sme 5000DRX · Traditional | Lectec Corp. | 08/28/1991SE |
| K910139 | Ver-Med A10014 Resting EKG Electrode & A10021DRX · Traditional | Vermont Medical, Inc. | 08/15/1991SE |
| K912714 | RT40 Radio TranslucentDRX · Traditional | Bio-Detek, Inc. | 07/25/1991SE |
| K911990 | ECG Female-To-Pin Snap Electrode W/Leads and Ext.DRX · Traditional | Somnitec, Inc. | 06/21/1991SE |
| K910494 | Resting EKG Electrode SeriesDRX · Traditional | Medtronic Andover Medical, Inc. | 04/22/1991SE |
| K905489 | Ver-Med A10017 Universal ElectrodeDRX · Traditional | Vermont Medical, Inc. | 03/21/1991SE |
| K905729 | Canmed 451DRX · Traditional | Andover Medical, Inc. | 02/07/1991SE |
| K905446 | Meditronic Andover Medical Model 1690 ElectrodeDRX · Traditional | Medtronic Andover Medical, Inc. | 02/05/1991SE |
| K904512 | Tracet AG 4000DRX · Traditional | Lectec Corp. | 01/31/1991SE |
| K903491 | MonitrodeDRX · Traditional | Lleventon | 12/17/1990SE |
| K903555 | Electrotrace Disposable Ag/Agcl EKG Mon. Elec.DRX · Traditional | Jason Marketing Co. | 11/05/1990SE |
| K904185 | SensatraceDRX · Traditional | Ludlow Corp., Technical Papers Division | 10/31/1990SE |
| K903918 | Model 1850 ElectrodeDRX · Traditional | Medtronic Vascular | 10/31/1990SE |
| K902738 | Electro Blue ECG Electrode-Pediatric ClothDRX · Traditional | Labeltape Meditect, Inc. | 09/04/1990SE |
| K902176 | Silver MactrodeDRX · Traditional | Marquette Electronics, Inc. | 09/04/1990SE |
| K902407 | NF-50-E Disposable ECG ElectrodeDRX · Traditional | Medicotest, Inc. | 07/31/1990SE |
| K902080 | Red Dot 2269 Infant Monitoring ElectrodeDRX · Traditional | 3M Company | 07/18/1990SE |
| K901555 | Model 1730 Neotrode with Attached LeadwireDRX · Traditional | Medtronic Vascular | 07/18/1990SE |
| K900519 | Classic Ecg/Stimulating No. 1700 SeriesDRX · Traditional | Classic Medical Products, Inc. | 03/19/1990SE |
| K896569 | Electrotrace Disposable Ag/Agcl EKG Monitor Elec.DRX · Traditional | Jason Marketing Co. | 01/18/1990SE |
| K896155 | Red Dot Cardiac Sensor SystemDRX · Traditional | 3M Company | 12/13/1989SE |
| K895834 | Baby Mac Electrocardiograph ElectrodeDRX · Traditional | Marquette Electronics, Inc. | 11/03/1989SE |
| K894991 | Electro Blue ECG Elect. Foam, Silver/Silver Chlo.DRX · Traditional | Labeltape Meditect, Inc. | 10/26/1989SE |
| K894462 | Care Disp. Diag. Electrodes, Silver/SilverDRX · Traditional | Labeltape Meditect, Inc. | 10/12/1989SE |
| K894920 | SelectrodeDRX · Traditional | S & W Medico Teknik | 10/03/1989SE |
| K894679 | Electrotrace Disp. Resting EKG ElectrodesDRX · Traditional | Jason Marketing Co. | 09/13/1989SE |
| K894648 | Arbo Tab Disposable Diagnostic Resting EKG ElectroDRX · Traditional | Arbo Medical, Inc. | 09/05/1989SE |
| K894562 | Arbo H79P Disposable Monitoring ElectrodesDRX · Traditional | Arbo Medical, Inc. | 09/05/1989SE |
| K893425 | VitatraceDRX · Traditional | Lectec Corp. | 07/14/1989SE |
| K893245 | L30-LB- Infant Limb BandDRX · Traditional | Contour Electrodes, Inc. | 06/20/1989SE |
| K884980 | F56 K Karaya Gum Disp. Pe-Foam ECG Electrode, 56MMDRX · Traditional | S & W Medico Teknik | 05/01/1989SE |
| K891075 | Bard Neonatal ECG Monitoring ElectrodeDRX · Traditional | C.R. Bard, Inc. | 03/22/1989SE |
| K890201 | Radiolucent ECG Electrode Model No: 1680DRX · Traditional | Medtronic Vascular | 03/15/1989SE |
| K884982 | M68 K Karaya Gum Disp. Microtape ECG ELECTRODE,68DRX · Traditional | S & W Medico Teknik | 03/10/1989SE |
| K884981 | F40 K Karaya Gum Disp. Pe-Foam ECG Electrode, 40MMDRX · Traditional | S & W Medico Teknik | 03/10/1989SE |
| K884984 | M40 K Karaya Gum Disp. Microtape ECG Electrode, 40DRX · Traditional | S & W Medico Teknik | 03/09/1989SE |
| K884983 | M55 K Karaya Gum Disp. Microtape ECG Electrode, 55DRX · Traditional | S & W Medico Teknik | 03/09/1989SE |
| K885306 | NuprepDRX · Traditional | Weaver & Co. | 02/23/1989SE |
| K884775 | Arbo Pink H82PDRX · Traditional | Arbo Medical, Inc. | 02/06/1989SE |
| K885262 | Polyhesive Monitoring and Diagnostic ElectrodesDRX · Traditional | Valleylab, Inc. | 01/25/1989SE |
| K890103 | Bard Tab ECG Monitoring ElectrodeDRX · Traditional | C.R. Bard, Inc. | 01/24/1989SE |
| K883643 | TDK ECG Electrode, MEL-10LDRX · Traditional | Tdk Corp. | 11/17/1988SE |
| K884064 | Bard Multi-Tac ECG Monitoring ElectrodeDRX · Traditional | C.R. Bard, Inc. | 10/06/1988SE |
| K882904 | TDK Electrode MEL-20-1, MEL-20-3, MEL-20-5DRX · Traditional | Tdk Corp. | 10/05/1988SE |
| K882216 | Syncor (R) Model S-801 ECG ElectrodeDRX · Traditional | Lectec Corp. | 07/20/1988SE |
| K881085 | Soft-E Series T-10 Accutrace Tab Resting ElectrodeDRX · Traditional | Contour Electrodes, Inc. | 04/11/1988SE |
| K875041 | Foam Bordered Diagnostic (Care) ElectrodeDRX · Traditional | Labeltape Meditect, Inc. | 01/28/1988SE |
| K875015 | Tracets 3000DRX · Traditional | Lectec Corp. | 01/28/1988SE |
| K874562 | SecuratrodeDRX · Traditional | Meddev International Corp. | 01/28/1988SE |
| K874424 | Pre-Gelled Disposable ECG Tape Electrode HP40489EDRX · Traditional | Hewlett-Packard Co. | 01/28/1988SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0940-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | Graphic Controls Acquisition Corporation | 03/15/2022Terminated |
| Z-0939-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | Graphic Controls Acquisition Corporation | 03/15/2022Terminated |
| Z-0938-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | Graphic Controls Acquisition Corporation | 03/15/2022Terminated |
| Z-0937-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | Graphic Controls Acquisition Corporation | 03/15/2022Terminated |
| Z-0936-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | Graphic Controls Acquisition Corporation | 03/15/2022Terminated |
| Z-0935-2022 Class II | CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | Graphic Controls Acquisition Corporation | 03/15/2022Terminated |
| Z-0188-2022 Class II | 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No.…Potential for breakage of the ECG electrode carbon stud from the eyelet. | 3M Company - Health Care Business | 10/06/2021Terminated |
| Z-0423-2021 Class II | 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by…Corrosion could cause performance failures in the product. | 3M Company - Health Care Business | 09/15/2020Terminated |
| Z-0422-2021 Class II | 3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by…Corrosion could cause performance failures in the product. | 3M Company - Health Care Business | 09/15/2020Terminated |
| Z-0421-2021 Class II | 3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by…Corrosion could cause performance failures in the product. | 3M Company - Health Care Business | 09/15/2020Terminated |
| Z-0420-2021 Class II | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended…Corrosion could cause performance failures in the product. | 3M Company - Health Care Business | 09/15/2020Terminated |
| Z-0419-2021 Class II | Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended…Corrosion could cause performance failures in the product. | 3M Company - Health Care Business | 09/15/2020Terminated |
| Z-0292-2016 Class II | ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60…There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that the affected… | Leonhard Lang Medizintechnik GmbH | 11/02/2015Terminated |
| Z-1350-2015 Class II | Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60…The electrodes may fail to transmit signals. | Leonhard Lang Medizintechnik GmbH | 02/24/2015Terminated |
| Z-1493-2011 | Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog…Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to… | ConMed Corporation | 09/23/2010Terminated |
| Z-2383-2010 | 3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode…The sensing element of the 3M Red Dot Monitoring Electrode, Catalog # 2560 and Novaplus Universal Monitoring… | 3M Company / Medical Division | 07/27/2010Terminated |
| Z-1776-2010 | The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary…Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit.… | Cambridge Heart, Inc. | 04/29/2010Terminated |
| Z-1431-2010 | Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoringIn an emergency situation where defibrillation is necessary and electrodes are already in use, the… | ConvaTec | 03/11/2010Terminated |