Medical Device Manufacturer · US , Agoura Hills , CA

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

22 submissions · 22 cleared · Since 2006

Recent clearances: Benesta Tissue Removal Device, 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, BenestaTM Tissue Removal Device

22

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - Caldera Medical, Inc. Obstetrics & Gynecology ✕

7 devices

1-7 of 7

Cleared Nov 30, 2023

Benesta Tissue Removal Device

Obstetrics & Gynecology · 30d

Cleared Oct 23, 2020

BenestaTM Tissue Removal Device

Obstetrics & Gynecology · 389d

Cleared Apr 06, 2015

Obstetrics & Gynecology · 91d

Cleared Apr 06, 2015

Vertessa Lite Y-Mesh

Obstetrics & Gynecology · 90d

Cleared Apr 25, 2013

VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH

Obstetrics & Gynecology · 209d

Cleared May 10, 2012

Obstetrics & Gynecology · 98d

Cleared Mar 31, 2009

Obstetrics & Gynecology · 106d