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Data / Medical devices / United States / Avive Solutions Inc

Avive Solutions Inc: FDA-registered device maker in Brisbane, CA, United States, 1 PMA approval

Avive Solutions Inc is registered with the FDA (registration 3026007685) in Brisbane, CA, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated October 31, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3026007685
Address
185 Valley Drive, Brisbane, CA, United States, 94005
Owner or operator
Avive Solutions Inc (10086420)
Roles
Manufacturer, Specification developer
First device listed
December 5, 2022
Registered through
2026
Brand names listed
Avive Automated External Defibrillator (AED) System, Avive Connect

Devices it lists

DeviceProduct codeClassRoleSource
Automated External Defibrillators (Non-Wearable)MKJ3Specification developeraccessdata.fda.gov
Medical Device Data SystemOUG1Manufactureraccessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
October 31, 2022P210015Avive Automated External Defibrillator (AED) SystemMKJ4August 13, 2025accessdata.fda.gov

Compare with other makers

Updated August 13, 2025. 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.