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. Gastroenterology & Urology ✕

10 devices

1-10 of 10

Cleared Nov 10, 2021

Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7...

Gastroenterology & Urology · 138d

Cleared Feb 07, 2020

Desara One Single Incision Sling System, 1 Pack

Gastroenterology & Urology · 255d

Cleared May 04, 2018

Caldera Medical Transobturator Helical Introducer, Left

Gastroenterology & Urology · 246d

Cleared Jan 11, 2017

Desara TV, Desara Blue TV

Gastroenterology & Urology · 159d

Cleared Sep 23, 2013

DESARA MESH, DESARA BLUE

Gastroenterology & Urology · 82d

Cleared Feb 19, 2013

Gastroenterology & Urology · 232d

Cleared Nov 30, 2011

Gastroenterology & Urology · 373d

Cleared Sep 30, 2011

Gastroenterology & Urology · 22d

Cleared May 20, 2010

DESARA MESH MODEL: CAL-DS01

Gastroenterology & Urology · 24d

Cleared May 08, 2008

DESARA MESH SLING, MODEL CAL-DS01

Gastroenterology & Urology · 251d