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CALDERA MEDICAL, INC.

US

Last updated September 17, 2026

Information

Country
US
Address
4360 Park Terrace Drive, Westlake Village, CA, 91361
Website
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LinkedIn
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Facebook
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Email
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Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3003990090
DUNS Number
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Catalogue (73)

Page 2 of 2
DeviceModel / ReferenceRegistriesClassStatus
Desara Mesh Model: Cal-Ds01 K101169
FDA 510(k)
Class IIActive
Desara Mesh Sling, Model Cal-Ds01 K072456
FDA 510(k)
Class IIActive
Ascend K083722
FDA 510(k)
Class IIIActive
BenestaTM Tissue Removal Device K192811
FDA 510(k)
Class IIActive
Desara TV, Desara Blue TV K162201
FDA 510(k)
Class IIActive
Desara Blue Ov, Desara Blue Ss K140843
FDA 510(k)
Class IIActive
Vertessa Lite Y-Mesh K150023
FDA 510(k)
Class IIActive
Desara Mesh, Desara Blue K132069
FDA 510(k)
Class IIActive
Desara Mini K103418
FDA 510(k)
Class IIActive
Vertessa Lite K150016
FDA 510(k)
Class IIActive
Benesta Medical Sterilization Tray K193603
FDA 510(k)
Class IIActive
Popmesh K053424
FDA 510(k)
Class IIActive
Benesta Tissue Removal Device K233500
FDA 510(k)
Class IIActive
Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System K211975
FDA 510(k)
Class IIActive
Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left K172614
FDA 510(k)
Class IIActive
Vertessa K120327
FDA 510(k)
Class IIActive
Benesta Hysteroscope K192822
FDA 510(k)
Class IIActive
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack K191416
FDA 510(k)
Class IIActive
Desara Sl K121928
FDA 510(k)
Class IIActive
Desara Mesh K112609
FDA 510(k)
Class IIActive
Vertessa Lite 10 X20cm, Vertessa Lite 11 X 30cm, Vertessa Lite Y-Mesh K123028
FDA 510(k)
Class IIActive
Caldera Mesh K060004
FDA 510(k)
Class IIActive
Ascend Blue Ac Mesh; Ascend Blue Pc Mesh K101462
FDA 510(k)
Class IIActive

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