Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 14, 2026, FDA's public records list Cardiac Science with 21 510(k) clearances and 2 device recalls. The most recent is a device recall dated Jun 4, 2019: Powerheart¿ G5 Automatic AED.
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.
| Jun 4, 2019 | Powerheart¿ G5 Automatic AEDClass II · Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices confo | Device recalls |
| Jan 14, 2016 | 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 913Class II · Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too high, the AED will fail | Device recalls |
| May 4, 2015 | Powerheart G5 AEDK143714 · MKJ | 510(k) clearances |
| Feb 12, 2014 | POWERHEART G5 AEDK122758 · MKJ | 510(k) clearances |
| Dec 21, 2011 | MYSENSE HEARTK113176 · DSH | 510(k) clearances |
| Jun 9, 2011 | POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUSK102496 · MKJ | 510(k) clearances |
| Jun 3, 2010 | CARECENTER MDK093211 · DPS | 510(k) clearances |
| Sep 10, 2009 | POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390AK091943 · MKJ | 510(k) clearances |
| Dec 12, 2008 | 9131 DEFIBRILLATION ELECTRODESK082090 · MKJ | 510(k) clearances |
| Aug 26, 2008 | Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4SK082173 · DPS | 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
