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Caldera Medical, Inc.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K233500 Benesta Tissue Removal DeviceHIH2023-11-30 View
510(k) K211975 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 SystemOTN2021-11-10 View
510(k) K192811 BenestaTM Tissue Removal DeviceHIH2020-10-23 View
510(k) K192822 Benesta HysteroscopeHIH2020-09-09 View
510(k) K193603 Benesta Medical Sterilization TrayKCT2020-07-20 View
510(k) K191416 Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackPAH2020-02-07 View
510(k) K172614 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 Medical Transobturator Inside-Out Introducer, LeftPWJ2018-05-04 View
510(k) K162201 Desara TV, Desara Blue TVOTN2017-01-11 View
510(k) K132069 DESARA MESH, DESARA BLUEOTN2013-09-23 View
510(k) K123028 VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESHOTO2013-04-25 View
510(k) K121928 DESARA SLOTN2013-02-19 View
510(k) K120327 VERTESSAOTO2012-05-10 View
510(k) K103418 DESARA MINIPAH2011-11-30 View
510(k) K112609 DESARA MESHOTN2011-09-30 View
510(k) K101462 ASCEND BLUE AC MESH; ASCEND BLUE PC MESHFTL2010-08-16 View
510(k) K101169 DESARA MESH MODEL: CAL-DS01OTN2010-05-20 View
510(k) K083722 ASCENDOTP2009-03-31 View
510(k) K072456 DESARA MESH SLING, MODEL CAL-DS01OTN2008-05-08 View
510(k) K053424 POPMESHFTL2006-02-22 View
510(k) K060004 CALDERA MESHFTL2006-02-22 View
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