ClearanceBrief
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)
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Top companies in DRX

Company510(k)sRecalls
Graphic Controls Corp.170
Nikomed U.S.A., Inc.120
Lectec Corp.110
Labeltape Meditect, Inc.100
Leonhard Lang Co.100
Andover Medical, Inc.80
Arbo Medical, Inc.70
S & W Medico Teknik70
3M Company - Health Care Business06
Conmed Andover Medical, Inc.60
DateFirm and productCodeLinked 510(k)
Mar 15, 2022Graphic Controls Acquisition Corporation
CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
Terminated		 DRXK101685
Mar 15, 2022Graphic Controls Acquisition Corporation
CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
Terminated		 DRXK101685
Mar 15, 2022Graphic Controls Acquisition Corporation
CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
Terminated		 DRXK101685
Mar 15, 2022Graphic Controls Acquisition Corporation
CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
Terminated		 DRXK101685
Mar 15, 2022Graphic Controls Acquisition Corporation
CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
Terminated		 DRXK101685
Mar 15, 2022Graphic Controls Acquisition Corporation
CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
Terminated		 DRXK101685
Oct 6, 20213M Company - Health Care Business
3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouc
Terminated		 DRXNone listed
Sep 15, 20203M Company - Health Care Business
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrode
Terminated		 DRXK970796
Sep 15, 20203M Company - Health Care Business
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50 electrodes per pouch; 20 pouches per shipper box (1000 electrode
Terminated		 DRXK970796
Sep 15, 20203M Company - Health Care Business
3M Red Dot Monitoring Electrode with 4mm Adapter - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 10 electrodes per card; 4 cards per pouch; 20 pouches per shipper
Terminated		 DRXK970796
Sep 15, 20203M Company - Health Care Business
Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 3 electrodes per card; 1 card per pouch; 200 pouches p
Terminated		 DRXK970796
Sep 15, 20203M Company - Health Care Business
Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches p
Terminated		 DRXK970796
Nov 18, 2015Leonhard Lang Medizintechnik GmbH
ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintact W-60HP E3 I 58046 Skintact T-60 I Patz K920 58688 Dahlhausen
Terminated		 DRXK024247
Mar 28, 2015Leonhard Lang Medizintechnik GmbH
Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547. To acquire and transmit the electrical signal at the body surface to a processor that prod
Terminated		 DRXK024247
Mar 2, 2011ConMed Corporation
Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003; Softrace Pediatric Wire Attached, Cata
Terminated		 DRXK901555
Sep 7, 20103M Company / Medical Division
3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring.
Terminated		 DRXK970796
Jun 7, 2010Cambridge Heart, Inc.
The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.
Terminated		 DRXK002230
Apr 22, 2010ConvaTec
Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring
Terminated		 DRXK990113
Aug 27, 2003Conmed Corporation
1690 Ultratrace Series ECG Electrodes, clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1690-001 (1 unit per pouch/30 per b
Terminated		 DRXK905446
Aug 27, 2003Conmed Corporation
1680 Invisatrace series ECG Electrodes, radiotranslucent clear tape ECG electrode with wet gel. This is a single use, disposable device. Electrodes are packaged and sold as: Cat No 1680-001 (1 uni
Terminated		 DRXK991105

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