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Sign in to claim this brandZoll Medical Corporation
United States·US-MF-000021386
Last updated September 17, 2026
What Zoll Medical Corporation makes
Zoll Medical Corporation manufactures automated and semi-automated external defibrillators, including rechargeable professional models, non-rechargeable public and semi-automated variants, and physiologic-monitoring defibrillation systems. Their portfolio also includes transport electric ventilators, reusable internal defibrillation electrodes for adults, and single-use electrocardiographic electrodes. Accessory kits for defibrillation and ECG monitoring are part of their product line.
The company’s devices are classified under FDA categories Class I, Class II, Class IIb, and Class III, with listings in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Zoll Medical Corporation primarily manufacture?
Zoll Medical Corporation specializes in defibrillation and respiratory support devices. Their portfolio includes automated and semi-automated external defibrillators, such as rechargeable professional models, non-rechargeable public variants, and systems that combine defibrillation with physiologic monitoring. They also produce transport electric ventilators, reusable internal defibrillation electrodes for adults, and single-use electrocardiographic electrodes. Accessory kits for defibrillation and ECG monitoring are also part of their offerings.
Where is Zoll Medical Corporation based, and does this affect its regulatory listings?
Zoll Medical Corporation is based in the United States. This location influences its regulatory presence, as the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database and the EU’s eudamed registry, reflecting compliance with both U.S. and European regulatory requirements. The U.S. classification system (Class I, II, IIb, and III) is used for FDA-authorized devices, while eudamed aligns with EU regulatory standards.
Which regulatory registries list Zoll Medical Corporation’s devices, and why are these important?
Zoll Medical Corporation’s devices are listed in the eudamed registry (for EU compliance) and the FDA’s UDI database (for U.S. regulatory tracking). These registries ensure transparency in device identification, traceability, and compliance with global regulatory frameworks. Listing in eudamed is mandatory for devices marketed in the EU, while FDA UDI listings support post-market surveillance and device recall coordination in the U.S.
How are Zoll Medical Corporation’s devices classified under FDA regulations?
Zoll Medical Corporation’s devices fall under FDA classification categories Class I, Class II, Class IIb, and Class III, depending on their risk level and intended use. Class III devices, such as certain defibrillators, require pre-market approval due to higher risk, while Class I or II devices may undergo less stringent review processes like 510(k) clearance. The classification determines the regulatory pathway for authorization, affecting documentation requirements and oversight.
Are Zoll Medical Corporation’s devices available globally, and how does this impact their regulatory status?
While Zoll Medical Corporation’s devices are designed for global use, their regulatory status varies by market. The company’s listings in eudamed and FDA UDI indicate compliance with EU and U.S. requirements, respectively, but other regions (e.g., Canada, Japan) may have separate registration processes. Each market’s regulatory body assesses devices independently, so availability depends on local authorization pathways, not just the company’s U.S. or EU listings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 269, Mill Road, Chelmsford, United States
- Website
- www.zoll.com
- —
- —
- [email protected]
- Phone
- +19784219655
- PRRC Contact
- Paul Dias
- EUDAMED SRN
- US-MF-000021386
- FDA FEI Number
- 1218058
- DUNS Number
- 055363428
Catalogue (3247)
Page 2 of 65| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Internal Handle | 1011-0140-03-11 | FDA UDI | Class II | Active |
| E Series | 50001010030164012 | FDA UDI | Class III | Active |
| X Series | 600-2231010-01-66 | FDA UDI | Class II | Active |
| E Series | 50011810030124013 | FDA UDI | Class III | Active |
| M Series Biphasic | 40021011110003010 | FDA UDI | Class II | Active |
| Aed Plus | 70000001302011010 | FDA UDI | Class III | Active |
| X Series | 601-0121411-01 | FDA UDI | Class III | Active |
| Powerheart G5, Semi, US Eng/ESP LA | G5S-80-L | FDA UDI | Class III | Active |
| Aed 3 | 1128-001205-27 | FDA UDI | Class III | Active |
| Aed 3 | 1128-001209-59 | FDA UDI | Class III | Active |
| Aed 3 | 1128-001204-27 | FDA UDI | Class III | Active |
| X Series | 610-0220011-01-66 | FDA UDI | Class II | Active |
| X Series | 600-0230510-01-66 | FDA UDI | Class II | Active |
| E Series | 50010430010164013 | FDA UDI | Class III | Active |
| E Series | 50011830020124012 | FDA UDI | Class III | Active |
| E Series | 50001910020124012 | FDA UDI | Class III | Active |
| R Series | 10000007201310013 | FDA UDI | Class II | Active |
| X Series | 620-2421511-01-66 | FDA UDI | Class II | Active |
| Powerheart® G5 Automatic AED | G5A-19P0 | FDA UDI | Class III | Active |
| X Series | 610-2431511-01 | FDA UDI | Class II | Active |
| X Series | 601-2231011-01-66 | FDA UDI | Class III | Active |
| X Series | 601-2271112-01 | FDA UDI | Class III | Active |
| R Series | 30001005201210362 | FDA UDI | Class II | Active |
| E Series | 50011840020164013 | FDA UDI | Class III | Active |
| Agile Test | TEST 8.6 | FDA UDI | Class II | Unknown |
| M Series | 40010211100163010 | FDA UDI | Class III | Active |
| E Series | 80001710010164012 | FDA UDI | Class III | Active |
| E Series | 50011710020064014 | FDA UDI | Class III | Active |
| Propaq M | 210-2231310-01 | FDA UDI | Class II | Active |
| Propaq M | 220-2221314-01 | FDA UDI | Class II | Active |
| Aed 3 | 1128-001105-01 | FDA UDI | Class III | Active |
| E Series | 50011730010164013 | FDA UDI | Class III | Active |
| E Series | 50001710030164013 | FDA UDI | Class III | Active |
| E Series | 80011710020164013 | FDA UDI | Class III | Active |
| Ecg | 1001-0032-02 | FDA UDI | Class II | Active |
| M Series | 60021711000163010 | FDA UDI | Class III | Active |
| X Series | 602-2221511-23-66 | FDA UDI | Class III | Active |
| X Series | 601-2231111-01-662 | FDA UDI | Class III | Active |
| Aed Plus | 70000001301011010 | FDA UDI | Class III | Active |
| Internal Handle | 3330-000002-02 | FDA UDI | Class II | Active |
| E Series | 50011910020164013 | FDA UDI | Class III | Active |
| M Series | 40021311000173010 | FDA UDI | Class III | Active |
| X Series | 600-2130011-01 | FDA UDI | Class III | Active |
| E Series | 50011730020064014 | FDA UDI | Class III | Active |
| Powerheart® G5 TSO Kit, Semi, US EN/LA ESP | G5S-80A-TSO | FDA UDI | Class III | Active |
| Vent | 800-EMVP-24-01 | FDA UDI | Class II | Active |
| X Series | 601-2121101-01 | FDA UDI | Class III | Active |
| Aed Plus | 22500710701011010 | FDA UDI | Class III | Active |
| E Series | 80001930020124013 | FDA UDI | Class III | Active |
| M Series Biphasic | 40010311110123010 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (16)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 13, 2025 | Z-1320-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1319-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1323-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1322-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1318-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1321-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1317-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| Feb 13, 2025 | Z-1316-2025 | — | open, classified | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). |
| May 31, 2024 | Z-2324-2024 | — | open, classified | G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest |
| Apr 30, 2024 | Z-2130-2024 | — | open, classified | Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy |
| Mar 5, 2014 | Z-1311-2014 | — | terminated | Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used |
| Aug 16, 2012 | Z-2401-2012 | — | terminated | Shipped with incorrect software |
| Apr 21, 2011 | Z-2294-2011 | — | terminated | Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy |
| Aug 2, 2004 | Z-1472-04 | — | terminated | Visual Sreen display and audible prompt may not advise to 'Press Shock' |
| Jun 23, 2003 | Z-1000-03 | — | terminated | Defibrillator may fail to charge or hold its charge above energies of 75 joules |
| Dec 17, 2002 | Z-0548-03 | — | terminated | Defibrillator may fail to function due to false detection of safety fault condition |