Home › Device types › OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
FDA product code OTN · Class 2 · General, Plastic Surgery
72
Registered devices
38,646
Adverse events
1
Recalls
65
510(k) clearances
Devices with this code
Align® RS Retropubic/Suprapubic Urethral Support System — C. R. Bard, Inc.I-STOP — CL MEDICALDesara TV — Caldera Medical, Inc.Desara — Caldera Medical, Inc.Conservia™ — BOSTON SCIENTIFIC CORPORATIONAdvantage Fit Ultra System — BOSTON SCIENTIFIC CORPORATIONRemeex System - Thread Passer — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLKIM (Knotless Incontinence Mesh) — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLAlign® TO Trans-Obturator Urethral Support System - Hook & Halo without Dilator — C. R. Bard, Inc.Desara — Caldera Medical, Inc.Remeex System - Passer Handle — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLAthena Surgical RMUS System — Athena Surgical LLCDesara TV — Caldera Medical, Inc.Advantage Ultra System — BOSTON SCIENTIFIC CORPORATIONKIM (Knotless Incontinence Mesh) — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLSupris — Coloplast A/SMonarc — ENDO PHARMACEUTICALS INC.GYNECARE TVT — Ethicon SàrlLynx™ Blue System — BOSTON SCIENTIFIC CORPORATIONDesara Blue TVez 2.7 — Caldera Medical, Inc.SPARC — ENDO PHARMACEUTICALS INC.Desara TVez 2.7 — Caldera Medical, Inc.GYNECARE TVT — Ethicon SàrlLynx Ultra System — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-10-15 | American Medical Systems, Inc. | During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle |
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