Home › Device types › MLN
Electrode, Electrocardiograph, Multi-Function
FDA product code MLN · Class 2 · Cardiovascular
97
Registered devices
1,348
Adverse events
9
Recalls
0
510(k) clearances
Devices with this code
Regard™ — Resource Optimization & Innovation, L.L.C.Henry Schein — HENRY SCHEIN, INC.Adult/Child, radiolucent, leads out, defib electrodes w/ Physio connector — HEART SYNC INCAdult/Child, radiotransparent, leads out, defib electrodes w/ Zoll connector — HEART SYNC INCRegard™ — Resource Optimization & Innovation, L.L.C.Medline — MEDLINE INDUSTRIES, INC.Heartsync by Vermed — GRAPHIC CONTROLS ACQUISITION CORPPHILIPS HeartStart SMARTPADS II — PHILIPS ELECTRONICS NORTH AMERICA CORPORATIONHenry Schein — HENRY SCHEIN, INC.PHILIPS HeartStart Pads Adapter for Zoll defibrillators — PHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMedline — MEDLINE INDUSTRIES, INC.Medline — MEDLINE INDUSTRIES, INC.Regard™ — Resource Optimization & Innovation, L.L.C.Adult/Child, radiotransparent, defib electrodes with large back-posterior pad w/ — HEART SYNC INCRegard™ — Resource Optimization & Innovation, L.L.C.Adult/Child, radiolucent, defib electrodes w/ Phillips connector — HEART SYNC INCMedline — MEDLINE INDUSTRIES, INC.Regard™ — Resource Optimization & Innovation, L.L.C.Regard™ — Resource Optimization & Innovation, L.L.C.Medline — MEDLINE INDUSTRIES, INC.Adult/Child, radiotransparent, defib electrodes with large back-posterior pad w/ — HEART SYNC INCPacific West Medical — PACIFIC WEST MEDICAL, INC.Curaplex — BOUND TREE MEDICAL, LLCRegard™ — Resource Optimization & Innovation, L.L.C.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-03-31 | ConMed Corporation | The specific lot was assembled without the rivet cover. |
| 2010-12-17 | Heart Sync, Inc | The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not |
| 2010-12-17 | Heart Sync, Inc | The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not |
| 2008-12-05 | Heart Sync, Inc | The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. |
| 2008-12-05 | Heart Sync, Inc | The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. |
| 2008-06-16 | Bio-Detek, Inc. | Multi-function electrode programmed as a Pediatric instead of Adult |
| 2007-03-08 | Conmed Corporation | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product un |
| 2007-03-08 | Conmed Corporation | Firm was notified of three incidents over the past 15 months in which customers opened the pouch & found an incorrect connector. This error makes the product un |
| 2005-11-18 | Philips Medical Systems | The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector |
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