Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list HeartSine Technologies with 10 device recalls and 6 510(k) clearances. The most recent is a 510(k) clearance dated Mar 27, 2015: samaritan PAD 450P.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 27, 2015 | samaritan PAD 450PK142709 · MKJ | 510(k) clearances |
| Jun 12, 2014 | Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External DefibrillaClass II · A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potenti | Device recalls |
| Jul 11, 2013 | HEARTSINE SAMARITAN PAD 350PK123881 · MKJ | 510(k) clearances |
| Sep 13, 2012 | HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210Class I · Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the abil | Device recalls |
| Dec 12, 2006 | REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351K052465 · MKJ | 510(k) clearances |
| Sep 2, 2004 | SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301K042088 · MKJ | 510(k) clearances |
| May 25, 2004 | HEARTSINE SAMARITAN PADK041067 · MKJ | 510(k) clearances |
| Feb 14, 2003 | SAMARITAN AED, MODEL SAM-01K023854 · 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
