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Heart Sync, Inc.

11 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips recall (Z-0583-2015)Heart Sync, Inc.2014-12-24
ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with recall (Z-0584-2015)Heart Sync, Inc.2014-12-24
ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philip recall (Z-0585-2015)Heart Sync, Inc.2014-12-24
ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips recall (Z-0586-2015)Heart Sync, Inc.2014-12-24
ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with recall (Z-0587-2015)Heart Sync, Inc.2014-12-24
Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic c recall (Z-1434-2013)Heart Sync, Inc2013-05-30
Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible d recall (Z-1435-2013)Heart Sync, Inc2013-05-30
Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for recall (Z-1950-2011)Heart Sync, Inc2011-04-12
Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO. Indicated for recall (Z-1951-2011)Heart Sync, Inc2011-04-12
Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250, HeartSync Ann Arbor, M recall (Z-1371-2011)Heart Sync, Inc2011-02-18
Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI. The Adult recall (Z-1372-2011)Heart Sync, Inc2011-02-18

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Every clearance here is in the API, with alerts when new ones post.