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Automated External Defibrillators (Non-Wearable)
FDA product code MKJ · Class 3 · Cardiovascular
4,010
Registered devices
268,693
Adverse events
334
Recalls
228
510(k) clearances
Devices with this code
AED 3 — Zoll Medical CorporationHeartStart MRx monitor/defib — Philips Medical Systems HsgLIFEPAK® 500 Automated External Defibrillator — PHYSIO-CONTROL, INC.LIFEPAK® 12 defibrillator/monitor — PHYSIO-CONTROL, INC.R&D Batteries, Inc. — R & D Batteries, Inc.LIFEPAK® 500 Automated External Defibrillator — PHYSIO-CONTROL, INC.HeartStart — PHILIPS ELECTRONICS NORTH AMERICA CORPORATIONLIFEPAK® 15 monitor/defibrillator — PHYSIO-CONTROL, INC.ZOLL MFC — Zoll Medical CorporationX SERIES — Zoll Medical CorporationLIFEPAK® 1000 defibrillator — PHYSIO-CONTROL, INC.R SERIES — Zoll Medical CorporationE SERIES — Zoll Medical CorporationAED 3 — Zoll Medical CorporationAED PLUS — Zoll Medical CorporationM SERIES BIPHASIC — Zoll Medical CorporationZOLL CABLE — Zoll Medical CorporationX SERIES — Zoll Medical CorporationPowerheart® AED G3 Automatic AED — Zoll Medical CorporationR SERIES — Zoll Medical CorporationX SERIES — Zoll Medical CorporationAED PLUS — Zoll Medical CorporationX SERIES — Zoll Medical CorporationLithium-ion Internal Battery — PHYSIO-CONTROL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-13 | Physio-Control, Inc. | Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was |
| 2026-01-21 | Physio-Control, Inc. | Due to pediatric defibrillator electrode delamination |
| 2025-09-18 | HeartSine Technologies Ltd | Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. |
| 2025-07-22 | Physio-Control, Inc. | Due to required inspections not being performed on products/units that have gone through servicing. |
| 2025-07-22 | Physio-Control, Inc. | Due to required inspections not being performed on products/units that have gone through servicing. |
| 2025-07-22 | Physio-Control, Inc. | Due to required inspections not being performed on products/units that have gone through servicing. |
| 2025-06-30 | HeartSine Technologies Ltd | Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks) |
| 2025-03-18 | Defibtech, LLC | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information |
| 2025-03-18 | Defibtech, LLC | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information |
| 2025-03-18 | Defibtech, LLC | It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information |
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