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ZOLL Circulation, Inc.

United States·US-MF-000008550

Last updated September 17, 2026

Information

Country: United States
Address: 2000, Ringwood Avenue, San Jose, United States
Website: zoll.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Doug Lam
EUDAMED SRN: US-MF-000008550
FDA FEI Number: 3003793491
DUNS Number: —

Catalogue (381)

Page 4 of 8

Device	Model / Reference	Registries	Class	Status
Thermogard XP, Lang set C, Rohs	ThermogardHQ, Lang set C	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse Battery	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse Li-ion Battery™	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
ThermoGard XP Surface Start-Up Kit	Surface Start-Up Kit	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse Li-ion Battery™	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
LifeBand® Load-distributing Band	100	FDA UDI	Class II	Active
AutoPulse Li-ion Battery™	100	FDA UDI	Class II	Active
QUATTRO® Intravascular Heat Exchange Catheter Kit Applause (Heparin)	IC-4593	FDA UDI	Class II	Active
AutoPulse Li-ion Battery™	100	FDA UDI	Class II	Active
Thermogard HQTM Start-Up Kit	TG2-500D	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
QUATTRO® Intravascular Heat Exchange Catheter Kit Applause (Heparin)	IC-4593AE	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
LifeBand® Load-distributing Band	100	FDA UDI	Class II	Active
AutoPulse Multi-Chemistry Battery Charger	100	FDA UDI	Class II	Active
LifeBand® Load-distributing Band	100	FDA UDI	Class II	Active
10.7f Packaged Accutrol Catheter	NA	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
Stx Surface Cooling	S/M PAD	FDA UDI	Class I	Active
ICY® Intravascular Heat Exchange Catheter Kit Surmodics Non Heparin	IC-3893AE	FDA UDI	Class II	Active
AutoPulse NXT	Model 200	FDA UDI	Class II	Active
Quattro, Heparin, Premium Kit, US	IC-4593	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse Charger	100	FDA UDI	Class II	Active
LifeBand® Load-distributing Band	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
LifeBand® Load-distributing Band	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
AutoPulse®Resuscitation System	100	FDA UDI	Class II	Active
LifeBand® Load-distributing Band	100	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (34)

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
Mar 4, 2025	Z-1533-2025	—	open, classified	AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
Sep 22, 2022	Z-0118-2023	—	open, classified	Due to increase in Li-Ion Battery failures
Aug 6, 2021	Z-0042-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0045-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0058-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0066-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0053-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0044-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0049-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0061-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0047-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0055-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0054-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0065-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0046-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0052-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0040-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0048-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0063-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0059-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0064-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0060-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0051-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0039-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0056-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0062-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0043-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0050-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0057-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Aug 6, 2021	Z-0041-2022	—	terminated	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Apr 1, 2014	Z-0477-2015	—	terminated	After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product was not filed.
Jul 16, 2013	Z-2090-2014	—	terminated	Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product.
Aug 8, 2012	Z-0658-2013	—	terminated	Complaints associated with an unexpected stop in AutoPulse compressions.
Jan 28, 2008	Z-1904-2011	—	terminated	Complaints of batteries discharging prematurely and that during use the Auto Pulse Units would cease operating (providing compressions).