BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CALDERA MEDICAL, INC.

    Reg #: 3003990090 · FEI: 3003990090 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    38
    Establishment Types
    3
    Classifications
    8

    Registration Details

    Registration Name
    CALDERA MEDICAL, INC.
    Registration Number
    3003990090
    FEI Number
    3003990090
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4360 Park Terrace Drive
    City
    Westlake Village
    State
    CA
    ZIP
    91361
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233500

    Owner / Operator

    Firm Name
    Caldera Medical
    Operator Number
    10028052
    Address
    4360 Park Terrace Drive
    City
    Westlake Village
    State
    CA
    Postal Code
    91361
    Country
    US

    Products

    Device Name Product Code
    Hysteroscope (And Accessories) HIH
    Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed OTO
    Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence PWJ
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Cutaneous Electrode Stimulator For Urinary Incontinence QAJ
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling PAH

    Proprietary Names

    Benesta Max Tissue Removal Device, 1/BX Benesta Tissue Removal Device, 3 pk Benesta Pro Tissue Removal Device, 1/BX + Outflow Tubing, 1/BX Benesta Max Tissue Removal Device, 1/BX + Outflow Tubing, 1/BX Benesta Tissue Removal Device, 1 pk Benesta Pro Tissue Removal Device, 1/BX Benesta Outflow Tubing, 10/BX Benesta Plus Tissue Removal Device, 1/BX Benesta Plus Tissue Removal Device, 1/BX + Outflow Tubing, 1/BX Benesta Outflow Tubing, 1/BX Vertessa Lite Y-Mesh Desara TVez 2.7mm Desara TVez 3mm Desara Blue TVez 2.7mm Desara Blue TVez 3mm Desara Desara Blue LUMINELLE DTx Hysteroscopy System Caldera Medical Surgical Mesh Instruments GYNECARE TVT™ Reusable Introducer, Reusable Rigid Catheter Guide, GYNECARE TVT EXACT™ Continence System Trocar GYNECARE TVT EXACT™ Continence System Desara SL Benesta Tissue Removal Device Benesta Hysteroscope GYNECARE TVT ABBREVO™ Continence System Desara Blue SS Desara Blue OV Desara TV and Desara Blue TV Innovo Benesta Steririlization Tray GYNECARE TVT™ Abdominal Guides and Couplers, Reusable Introducer, Reusable Rigid Catheter Guide Desara One Single Incision Sling GYNECARE TVT™ Obturator Device GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide Vertessa Lite LUMINELLE DTx System Luminelle DTx Hysteroscopy System GYNECARE TVT™ System, Abdominal Guides System, Introducer and Catheter Guide, EXACT™, Obturator, ABBREVO™

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility