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Lazarus 3D

Also registered as Lazarus 3D, Inc.

United Statesfrom the FDA registration address FDA FEI 3020858025

Lazarus 3D is a medical device manufacturer, with 4 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 12 Nov 2026.

Devices
4
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA 510(k) 2
  • FDA GUDID 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 4
Identifiers
  • FDA FEI 3020858025

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI

What Lazarus 3D makes

Lazarus 3D makes radiology information system application software, including the Pre-Sure device.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

  • Pre-Sure 1

    Listed Registry: GUDID Class:II
  • Pre-Sure 1

    Listed Registry: GUDID Class:II
  • Pre-Sure Ref K201835

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Pre-Sure Ref K230044

    Active Regimes: 510(k) Registry: 510(k) Class:II

Company details

FDA FEI number
3020858025
Address
Lazarus 3D, Inc., Philomath, OR, 97370

Frequently asked questions

How many devices does Lazarus 3D have in the registry?

The registry currently lists 4 devices for Lazarus 3D. Devices recorded under merged duplicate company entries are counted once.

Which registries list Lazarus 3D's devices?

Among its 4 most recently registered devices, Lazarus 3D has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Lazarus 3D's devices fall under?

Among its 4 most recently registered devices, the classes recorded for Lazarus 3D's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Lazarus 3D in the registry?

The most recently registered devices listed for Lazarus 3D include Pre-Sure 1 and PRE-SURE.

Generated automatically from registry data and not verified by a human reviewer.