Company ยท US
Caldera Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2023. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 8 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 5 |
| FTL | Mesh, Surgical, Polymeric | 3 |
| HIH | Hysteroscope (And Accessories) | 3 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | 2 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 |
| OTP | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | 1 |
| PWJ | Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 30, 2023 | K233500 | Benesta Tissue Removal Device Caldera Medical, Inc. | HIH |
| Nov 10, 2021 | 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 System Caldera Medical, Inc. | OTN |
| Oct 23, 2020 | K192811 | BenestaTM Tissue Removal Device Caldera Medical, Inc. | HIH |
| Sep 9, 2020 | K192822 | Benesta Hysteroscope Caldera Medical, Inc. | HIH |
| Jul 20, 2020 | K193603 | Benesta Medical Sterilization Tray Caldera Medical, Inc. | KCT |
| Feb 7, 2020 | K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack Caldera Medical, Inc. | PAH |
| May 4, 2018 | K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Calde Caldera Medical, Inc. | PWJ |
| Jan 11, 2017 | K162201 | Desara TV, Desara Blue TV Caldera Medical, Inc. | OTN |
| Apr 6, 2015 | K150023 | Vertessa Lite Y-Mesh Caldera Medical, Inc. | OTO |
| Apr 6, 2015 | K150016 | Vertessa Lite Caldera Medical, Inc. | OTO |
| Jul 1, 2014 | K140843 | DESARA BLUE OV, DESARA BLUE SS Caldera Medical | OTN |
| Sep 23, 2013 | K132069 | DESARA MESH, DESARA BLUE Caldera Medical, Inc. | OTN |
| Apr 25, 2013 | K123028 | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LITE Y-MESH Caldera Medical, Inc. | OTO |
| Feb 21, 2013 | K123337 | VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM Caldera Medical | OTO |
| Feb 19, 2013 | K121928 | DESARA SL Caldera Medical, Inc. | OTN |
| May 10, 2012 | K120327 | VERTESSA Caldera Medical, Inc. | OTO |
| Nov 30, 2011 | K103418 | DESARA MINI Caldera Medical, Inc. | PAH |
| Sep 30, 2011 | K112609 | DESARA MESH Caldera Medical, Inc. | OTN |
| Aug 16, 2010 | K101462 | ASCEND BLUE AC MESH; ASCEND BLUE PC MESH Caldera Medical, Inc. | FTL |
| May 20, 2010 | K101169 | DESARA MESH MODEL: CAL-DS01 Caldera Medical, Inc. | OTN |
| Mar 31, 2009 | K083722 | ASCEND Caldera Medical, Inc. | OTP |
| May 8, 2008 | K072456 | DESARA MESH SLING, MODEL CAL-DS01 Caldera Medical, Inc. | OTN |
| Feb 22, 2006 | K060004 | CALDERA MESH Caldera Medical, Inc. | FTL |
| Feb 22, 2006 | K053424 | POPMESH Caldera Medical, Inc. | FTL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||