Caldera Medical Inc

FDA Filings

This page includes the latest FDA filings for Caldera Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003990090
FEI Number3003990090
NameCALDERA MEDICAL, INC.
Owner & OperatorCaldera Medical
Contact Address5171 Clareton Dr
Agoura Hills CA 91301 US
Official Correspondent
  • Vicki Gail
  • x-818-8796555-102
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5171 Clareton Dr
Agoura Hills, CA 91301 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Caldera Medical, Inc.
Benesta Hysteroscope2020-09-09
CALDERA MEDICAL, INC.
Desara One 2020-03-04
CALDERA MEDICAL, INC.
Desara One 2020-03-04
CALDERA MEDICAL, INC. [Caldera Medical]
Desara One Single Incision Sling2020-02-11
CALDERA MEDICAL, INC. [Caldera Medical]
Desara One Single Incision Sling2020-02-11
Caldera Medical, Inc.
Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack2020-02-07
CALDERA MEDICAL, INC.
Transobturator Inside-Out, Left 3.2 mm Introducer CAL-IOL322019-11-13
CALDERA MEDICAL, INC.
Transobturator Inside-Out, Right 3.2 mm Introducer CAL-IOR322019-11-13
CALDERA MEDICAL, INC.
Desara TV CAL-DS01TV2019-10-08
CALDERA MEDICAL, INC.
Desara CAL-DS012019-10-08
CALDERA MEDICAL, INC.
Transvaginal 3.2 mm Introducer CAL-TV322019-10-08
CALDERA MEDICAL, INC.
Desara Blue TV CAL-DS01BTV2019-10-08
CALDERA MEDICAL, INC.
Winged Guide Accessory CAL-WI2019-10-08
CALDERA MEDICAL, INC.
Transvaginal 4.0 mm Introducer CAL-TV022019-10-08
CALDERA MEDICAL, INC.
Suprapubic Introducer CAL-SP012019-10-08
CALDERA MEDICAL, INC.
Transobturator Hook Introducer CAL-TB032019-10-08
CALDERA MEDICAL, INC.
Transobturator Inside-Out, Right Introducer CAL-IO72019-10-08
CALDERA MEDICAL, INC.
Transobturator Inside-Out, Left Introducer CAL-IO62019-10-08
CALDERA MEDICAL, INC.
Transobturator Large Helical, Right Introducer CAL-LHR22019-10-08
CALDERA MEDICAL, INC.
Transobturator Large Helical, Left Introducer CAL-LHL12019-10-08
CALDERA MEDICAL, INC.
Transobturator Helical, Right Introducer CAL-HR052019-10-08
CALDERA MEDICAL, INC.
Transobturator Helical, Left Introducer CAL-HL042019-10-08
CALDERA MEDICAL, INC.
Vertessa Lite Y-Mesh 26x5x4cm 2019-09-26
CALDERA MEDICAL, INC.
Desara SL 2019-09-26
CALDERA MEDICAL, INC.
Desara TV 2019-04-23
CALDERA MEDICAL, INC.
Desara Blue Short Suture Sling 2019-04-23
CALDERA MEDICAL, INC.
Desara Blue OV 2019-04-23
CALDERA MEDICAL, INC.
Desara Blue 2019-04-23
CALDERA MEDICAL, INC.
Desara 2019-04-23
CALDERA MEDICAL, INC.
Desara SL 2019-04-23
CALDERA MEDICAL, INC. [Caldera Medical]
Caldera Medical Surgical Mesh Instruments2018-05-21
Caldera Medical, Inc.
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 2018-05-04
CALDERA MEDICAL, INC. [Caldera Medical]
Desara TV and Desara Blue TV2017-01-13
CALDERA MEDICAL, INC.
Desara TV, Desara Blue TV2017-01-11
CALDERA MEDICAL, INC. [Caldera Medical]
Vertessa Lite Y-Mesh2015-07-07
CALDERA MEDICAL, INC. [Caldera Medical]
Vertessa Lite2015-07-07
CALDERA MEDICAL, INC.
Vertessa Lite Y-Mesh2015-04-06
CALDERA MEDICAL, INC.
Vertessa Lite2015-04-06
CALDERA MEDICAL, INC. [Caldera Medical]
Desara Blue SS2014-12-08
CALDERA MEDICAL, INC. [Caldera Medical]
Desara Blue OV2014-12-08
CALDERA MEDICAL, INC. [Caldera Medical]
Desara2013-12-06
CALDERA MEDICAL, INC. [Caldera Medical]
Desara Blue2013-12-06
CALDERA MEDICAL, INC. [Caldera Medical]
Vertessa Lite Y-Mesh2013-12-06
CALDERA MEDICAL, INC.
DESARA MESH, DESARA BLUE2013-09-23
CALDERA MEDICAL, INC.
VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH2013-04-25
CALDERA MEDICAL, INC. [Caldera Medical]
Vertessa Lite Flat Mesh, 11 x 30cm2013-03-04
CALDERA MEDICAL, INC. [Caldera Medical]
Vertessa Lite Flat Mesh, 10 x 20cm2013-03-04
CALDERA MEDICAL, INC. [Caldera Medical]
Desara SL2013-03-04
CALDERA MEDICAL, INC.
DESARA SL2013-02-19
CALDERA MEDICAL, INC. [Caldera Medical]
Vertessa2012-11-30
CALDERA MEDICAL, INC.
VERTESSA2012-05-10
CALDERA MEDICAL, INC.
DESARA MINI2011-11-30
CALDERA MEDICAL, INC. [Caldera Medical]
Desara Mesh2011-11-30
CALDERA MEDICAL, INC. [Caldera Medical]
Desara2011-11-30
CALDERA MEDICAL, INC.
DESARA MESH2011-09-30
CALDERA MEDICAL, INC.
ASCEND BLUE AC MESH; ASCEND BLUE PC MESH2010-08-16
CALDERA MEDICAL, INC.
DESARA MESH MODEL: CAL-DS012010-05-20
CALDERA MEDICAL, INC. [Caldera Medical]
Desara2008-12-24
CALDERA MEDICAL, INC.
DESARA MESH SLING, MODEL CAL-DS012008-05-08
CALDERA MEDICAL, INC.
CALDERA MESH2006-02-22

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