Home / Companies / Caldera Medical, Inc.

Caldera Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
24
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233500Benesta Tissue Removal DeviceNovember 30, 2023
K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.November 10, 2021
K192811BenestaTM Tissue Removal DeviceOctober 23, 2020
K192822Benesta HysteroscopeSeptember 9, 2020
K193603Benesta Medical Sterilization TrayJuly 20, 2020
K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackFebruary 7, 2020
K172614Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical IntrMay 4, 2018
K162201Desara TV, Desara Blue TVJanuary 11, 2017
K150016Vertessa LiteApril 6, 2015
K150023Vertessa Lite Y-MeshApril 6, 2015
K140843DESARA BLUE OV, DESARA BLUE SSJuly 1, 2014
K132069DESARA MESH, DESARA BLUESeptember 23, 2013
K123028VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESHApril 25, 2013
K123337VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CMFebruary 21, 2013
K121928DESARA SLFebruary 19, 2013
K120327VERTESSAMay 10, 2012
K103418DESARA MININovember 30, 2011
K112609DESARA MESHSeptember 30, 2011
K101462ASCEND BLUE AC MESH; ASCEND BLUE PC MESHAugust 16, 2010
K101169DESARA MESH MODEL: CAL-DS01May 20, 2010