Panels › Cardiovascular › Product code MLN · Class 2
Electrode, Electrocardiograph, Multi-Function
Regulation 870.2360
0510(k)s in 12 months (0 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in MLN
| Company | 510(k)s | Recalls |
|---|---|---|
| Heart Sync, Inc | 0 | 4 |
| ConMed Corporation | 0 | 3 |
| Bio-Detek, Inc. | 0 | 1 |
| Philips Medical Systems | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2012 | ConMed Corporation R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13507
This device, when connected to a monito Terminated |
MLN | K964469 |
| Apr 12, 2011 | Heart Sync, Inc Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO.
Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for si Terminated |
MLN | K080421 |
| Apr 12, 2011 | Heart Sync, Inc Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242.
Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for Terminated |
MLN | K080421 |
| Feb 18, 2011 | Heart Sync, Inc Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI.
The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and moni Terminated |
MLN | K080421 |
| Feb 18, 2011 | Heart Sync, Inc Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann Arbor, MI.
The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillat Terminated |
MLN | K080421 |
| Sep 20, 2008 | Bio-Detek, Inc. ZOLL OneStep Multi-Function Electrode; Adult Complete
Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, an Terminated |
MLN | K051076 |
| Apr 24, 2007 | Conmed Corporation PADPRO ADULT Radiotranslucent Pad w/Medtronic connector, REF/Catalog #2516M. RX ONLY. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes. Made in USA for: CONMED CORPORATION Utica, New York, 13 Terminated |
MLN | K020203 |
| Apr 24, 2007 | Conmed Corporation PADPRO ADULT Radiotranslucent Pad w/Zoll connector. Defibrillation/Pacing/Cardioversion/Monitoring Electrodes, REF/Catalog # 2516Z. RX ONLY. Made in USA for: CONMED CORPORATION Utica, New York, 13502. Terminated |
MLN | K020203 |
| Dec 23, 2005 | Philips Medical Systems HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads
Model M3717A Terminated |
MLN | K003228 |
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