Caldera Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Caldera Medical, Inc. - FDA 510(k) Cleared Devices
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
Caldera Medical, Inc. has 22 FDA 510(k) cleared medical devices. Based in Agoura Hills, US.
Last cleared in 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.
FDA 510(k) Regulatory Record - Caldera Medical, Inc.
22 devices
Cleared
Nov 30, 2023
Benesta Tissue Removal Device
Obstetrics & Gynecology
30d
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
Oct 23, 2020
BenestaTM Tissue Removal Device
Obstetrics & Gynecology
389d
Cleared
Sep 09, 2020
Benesta Hysteroscope
General Hospital
344d
Cleared
Jul 20, 2020
Benesta Medical Sterilization Tray
General Hospital
210d
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
Apr 06, 2015
Vertessa Lite
Obstetrics & Gynecology
91d
Cleared
Apr 06, 2015
Vertessa Lite Y-Mesh
Obstetrics & Gynecology
90d
Cleared
Sep 23, 2013
DESARA MESH, DESARA BLUE
Gastroenterology & Urology
82d
Cleared
Apr 25, 2013
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH
Obstetrics & Gynecology
209d
Cleared
Feb 19, 2013
DESARA SL
Gastroenterology & Urology
232d
Cleared
May 10, 2012
VERTESSA
Obstetrics & Gynecology
98d
Cleared
Nov 30, 2011
DESARA MINI
Gastroenterology & Urology
373d
Cleared
Sep 30, 2011
DESARA MESH
Gastroenterology & Urology
22d
Cleared
Aug 16, 2010
ASCEND BLUE AC MESH
General & Plastic Surgery
82d
Cleared
May 20, 2010
DESARA MESH MODEL: CAL-DS01
Gastroenterology & Urology
24d
Cleared
Mar 31, 2009
ASCEND
Obstetrics & Gynecology
106d
Cleared
May 08, 2008
DESARA MESH SLING, MODEL CAL-DS01
Gastroenterology & Urology
251d
Cleared
Feb 22, 2006
POPMESH
General & Plastic Surgery
76d
Cleared
Feb 22, 2006
CALDERA MESH
General & Plastic Surgery
50d