Medical Device Manufacturer · US , Agoura Hills , CA

Caldera Medical, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2006
22
Total
22
Cleared
0
Denied

Caldera Medical, Inc. has 22 FDA 510(k) cleared medical devices. Based in Agoura Hills, US.

Latest FDA clearance: Nov 2023. Active since 2006. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Caldera Medical, Inc. Filter by specialty or product code using the sidebar.

22 devices
1–12 of 22
Benesta Tissue Removal Device
K233500 · HIH Hysteroscope (and Accessories) · Obstetrics & Gynecology
Nov 2023 30d
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 · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · Gastroenterology & Urology
Nov 2021 138d
BenestaTM Tissue Removal Device
K192811 · HIH Hysteroscope (and Accessories) · Obstetrics & Gynecology
Oct 2020 389d
Benesta Hysteroscope
K192822 · HIH Hysteroscope (and Accessories) · General Hospital
Sep 2020 344d
Benesta Medical Sterilization Tray
K193603 · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories · General Hospital
Jul 2020 210d
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack
K191416 · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling · Gastroenterology & Urology
Feb 2020 255d
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 · PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence · Gastroenterology & Urology
May 2018 246d
Desara TV, Desara Blue TV
K162201 · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · Gastroenterology & Urology
Jan 2017 159d
Vertessa Lite
K150016 · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · Obstetrics & Gynecology
Apr 2015 91d
Vertessa Lite Y-Mesh
K150023 · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · Obstetrics & Gynecology
Apr 2015 90d
DESARA MESH, DESARA BLUE
K132069 · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · Gastroenterology & Urology
Sep 2013 82d
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
K123028 · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed · Obstetrics & Gynecology
Apr 2013 209d
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All22 Gastroenterology & Urology 10 Obstetrics & Gynecology 7 General & Plastic Surgery 3 General Hospital 2