Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Heart Sync, Inc. with 7 device recalls and 5 510(k) clearances. The most recent is a 510(k) clearance dated Dec 6, 2013: HEART SYNC.
| Date | Record | Source |
|---|---|---|
| Dec 6, 2013 | HEART SYNCK131550 · MKJ | 510(k) clearances |
| Sep 16, 2013 | HEART SYNCK131494 · MKJ | 510(k) clearances |
| Apr 26, 2013 | Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECClass II · On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100- | Device recalls |
| Apr 26, 2013 | Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG MonitoringClass II · On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100- | Device recalls |
| Aug 6, 2012 | HEART SYNC PEDIATRIC PHYSIO AED PADK120536 · MKJ | 510(k) clearances |
| Sep 24, 2008 | HEART SYNC PEDIATRIC, MODEL PED-100K081442 · LDD | 510(k) clearances |
| Feb 29, 2008 | HEART SYNC, MODELS C-100 AND T-100K080421 · MKJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
