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Data / Medical devices / Netherlands / ZOLL International Holding B.V.

ZOLL International Holding B.V.: FDA-registered device maker in Elst Gelderland, Netherlands, 14 510(k) clearances and 6 PMA approvals

ZOLL International Holding B.V. is registered with the FDA (registration 3029871637) in Elst Gelderland, Netherlands. It lists 25 device types. The FDA files 14 510(k) clearances and 6 PMA approvals under its listings, the newest dated October 15, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch ZOLL International Holding B.V.
FDA registration number
3029871637
Address
Einsteinweg 8A, Elst Gelderland, Netherlands, 6662 PW
Owner or operator
ZOLL Medical Corporation (1220908)
Roles
Exporter to the US
First device listed
December 6, 2013
Registered through
2026
Brand names listed
731 Series, ACCUVENT SENSOR DISPOSABLE, AEV, Autopulse Resuscitation System Model 100, Cool Line Intravascular Heat Exchange Catheter, Coolgard 3000 Console, EMV+, Eagle II and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Exporter to the USaccessdata.fda.gov
Automated External Defibrillators (Non-Wearable)MKJ3Exporter to the USaccessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)BZN1Exporter to the USaccessdata.fda.gov
Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory ValvePIZ3Exporter to the USaccessdata.fda.gov
Compressor, Cardiac, ExternalDRM2Exporter to the USaccessdata.fda.gov
Computer, Blood-PressureDSK2Exporter to the USaccessdata.fda.gov
Continuous Measurement ThermometerFLL2Exporter to the USaccessdata.fda.gov
Display, Cathode-Ray Tube, MedicalDXJ2Exporter to the USaccessdata.fda.gov
ElectrocardiographDPS2Exporter to the USaccessdata.fda.gov
Hyperthermia MonitorNZE2Exporter to the USaccessdata.fda.gov
Kit, First Aid, TalkingOVR1Exporter to the USaccessdata.fda.gov
Mattress, Water, Temperature RegulatedFOH1Exporter to the USaccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Exporter to the USaccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Exporter to the USaccessdata.fda.gov
OximeterDQA2Exporter to the USaccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Exporter to the USaccessdata.fda.gov
Sleeve, Limb, CompressibleJOW2Exporter to the USaccessdata.fda.gov
Spirometer, Therapeutic (Incentive)BWF2Exporter to the USaccessdata.fda.gov
Strap, Head, Gas MaskBTK1Exporter to the USaccessdata.fda.gov
System, Hypothermia, Intravenous, CoolingNCX2Exporter to the USaccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Exporter to the USaccessdata.fda.gov
System, Oxygen, AqueousMWG3Exporter to the USaccessdata.fda.gov
System, Thermal RegulatingDWJ2Exporter to the USaccessdata.fda.gov
Transducer, Gas FlowBXP1Exporter to the USaccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 15, 2025K250979Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad)NZESubstantially EquivalentZoll Circulation, Inc.accessdata.fda.gov
December 13, 2024K233486731 Series VentilatorCBKSubstantially EquivalentZOLL Medical Corporationaccessdata.fda.gov
November 3, 2023K231182Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management SystemNZESubstantially EquivalentZoll Circulation, Inc.accessdata.fda.gov
March 9, 2023K221700AutoPulse NXT Resuscitation SystemDRMSubstantially EquivalentZoll Circulation, Inc.accessdata.fda.gov
January 13, 2023K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ ConsoleNCXUnknownZoll Circulation, Inc.accessdata.fda.gov
June 2, 2022K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ ConsoleNCXUnknownZoll Circulation, Inc.accessdata.fda.gov
December 20, 2021K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP ConsoleNCXUnknownZoll Circulation, Inc.accessdata.fda.gov
March 9, 2021K202375ZOLL Propaq MMWISubstantially EquivalentZOLL Medical Corporationaccessdata.fda.gov
April 18, 2017K170533Model 330 Multifunction AspiratorBTASubstantially EquivalentZOLL Medical Corporationaccessdata.fda.gov
March 24, 2016K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCXUnknownZoll Circulation, Inc.accessdata.fda.gov
October 3, 2014K141139SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETERNCXSubstantially EquivalentZoll Circulationaccessdata.fda.gov
April 3, 2014K132488ZOLL CODE WRITERDXJSubstantially EquivalentZOLL Medical Corporationaccessdata.fda.gov
March 19, 2008K072527AUTOPULSE RESUSCITATION SYSTEM, MODEL 100DRMSubstantially EquivalentZoll Circulationaccessdata.fda.gov
November 20, 2003K033401MODIFICATION TO RESQPOD CIRCULATORY ENHANCERBWFSubstantially EquivalentAdvanced Circulatory Systems, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
April 2, 2019P170027TherOx Downstream SystemMWG20April 10, 2026accessdata.fda.gov
December 7, 2018P160033Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3MKJ9April 28, 2026accessdata.fda.gov
December 6, 2018P160034Powerheart® AED G3 ProMKJ2March 1, 2020accessdata.fda.gov
December 27, 2017P160022X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™MKJ52October 16, 2026accessdata.fda.gov
May 26, 2017P160015AED Plus and Fully Automatic AED PlusMKJ27October 16, 2026accessdata.fda.gov
March 6, 2015P110024RESQCPR SYSTEMPIZ5August 27, 2026accessdata.fda.gov

Compare with other makers

Updated April 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.