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Esi, Inc.

Also registered as Esi

United StatesFDA applicant, unverified FDA FEI 3004181533

Esi, Inc. is a medical device manufacturer, with 26 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 14 Nov 2026.

Devices
26
Registrations
FDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries
  • FDA GUDID 23
  • FDA 510(k) 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 24
  • FDA Class I 2
Identifiers
  • FDA FEI 3004181533

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI

Catalogue26

Newest first, rows 1-26 of 26

Search and filter all 26 devices
Skip device list
  • Prager Shell® P-103GS

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P106SVGS P106SV Gold Series

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-106

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Kera-Flow KF100

    Listed Registry: GUDID Class:I
  • Prager Shell® P-104SV

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Ext Set A1236 011B1236 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Ext Set B1263 011B1263 Open recall

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-103

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-104

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-102-2

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-110RXP

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-102

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-105

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-100-AS

    Active Regimes: 510(k) Registry: GUDID Class:II
  • ClearScan® CS200

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-101

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-104GS

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-106GS

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-107-2

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-103SV

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-106SV

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-100

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Prager Shell® P-101-2

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Clearscan Ref K080119

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Afterloading Gynecological Applicator Ref K813230

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Prager Shell Ref K082893

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

Rows 1-26 of 26

Company details

FDA FEI number
3004181533
Address
2915 EVEREST LN N, Minneapolis, MN, 55447

Frequently asked questions

How many devices does Esi, Inc. have in the registry?

The registry currently lists 26 devices for Esi, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Esi, Inc.'s devices?

Among its 26 most recently registered devices, Esi, Inc. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (23 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Esi, Inc.'s devices fall under?

Among its 26 most recently registered devices, the classes recorded for Esi, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Esi, Inc. in the registry?

The most recently registered devices listed for Esi, Inc. include Prager Shell® P-103GS, PRAGER SHELL® P106SVGS P106SV GOLD SERIES, Prager Shell® P-106 and Kera-Flow KF100.

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