Company ยท US
Heart Sync, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2013. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 6, 2013 | K131550 | HEART SYNC Heart Sync, Inc. | MKJ |
| Sep 16, 2013 | K131494 | HEART SYNC Heart Sync, Inc. | MKJ |
| Aug 6, 2012 | K120536 | HEART SYNC PEDIATRIC PHYSIO AED PAD Heart Sync, Inc. | MKJ |
| Sep 24, 2008 | K081442 | HEART SYNC PEDIATRIC, MODEL PED-100 Heart Sync, LLC | LDD |
| Feb 29, 2008 | K080421 | HEART SYNC, MODELS C-100 AND T-100 Heart Sync, LLC | MKJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 24, 2014 | Heart Sync, Inc. ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended fo Terminated |
MKJ | K080421 |
| Dec 24, 2014 | Heart Sync, Inc. ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use du Terminated |
MKJ | K080421 |
| Dec 24, 2014 | Heart Sync, Inc. ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use Terminated |
MKJ | K080421 |
| Dec 24, 2014 | Heart Sync, Inc. ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended f Terminated |
MKJ | K080421 |
| Dec 24, 2014 | Heart Sync, Inc. ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use d Terminated |
MKJ | K080421 |
| May 30, 2013 | Heart Sync, Inc Vermed, Inc Radiotransparent Defibrillation Electrodes
Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes.
Used in connection with a defibrillator to deli Terminated |
LDF | K080421 |
| May 30, 2013 | Heart Sync, Inc Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes
Used in connection with a defibrill Terminated |
LDF | K080421 |
| 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 |