Home › Device types › OTO
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
FDA product code OTO · Class 2 · General, Plastic Surgery
29
Registered devices
4,773
Adverse events
1
Recalls
23
510(k) clearances
Devices with this code
Restorelle — Coloplast A/SDesara Blue — Caldera Medical, Inc.Vertessa Lite Y-mesh 22x4x3cm — Caldera Medical, Inc.Vertessa Lite Strips 4x22cm — Caldera Medical, Inc.IntePro Y-Mesh — ENDO PHARMACEUTICALS INC.Desara Blue OV — Caldera Medical, Inc.Alyte™ Y-Mesh Graft — C. R. Bard, Inc.Coloplast — Coloplast A/SPolyform™ — BOSTON SCIENTIFIC CORPORATIONGYNECARE GYNEMESH — ETHICON, LLCDesara SL — Caldera Medical, Inc.Vertessa Lite 10x22cm — Caldera Medical, Inc.Vertessa Lite Y-Mesh 26x4x3cm — Caldera Medical, Inc.Upsylon™ — BOSTON SCIENTIFIC CORPORATIONGYNECARE GYNEMESH — ETHICON, LLCVertessa Lite 10x26cm — Caldera Medical, Inc.Restorelle — Coloplast A/SVertessa Lite Y 22x5x4cm — Caldera Medical, Inc.Restorelle — Coloplast A/SRestorelle — Coloplast A/SVertessa Lite Y-Mesh 26x5x4cm — Caldera Medical, Inc.Desara Blue Short Suture Sling — Caldera Medical, Inc.Restorelle — Coloplast A/SPolyform™ — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-04-12 | Coloplast Manufacturing US, LLC | Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packa |
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