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Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

FDA product code OTN · Class 2 · General, Plastic Surgery

72
Registered devices
38,668
Adverse events
1
Recalls
65
510(k) clearances

Devices with this code

NA — ENDO PHARMACEUTICALS INC.Obtryx™ System - Curved — BOSTON SCIENTIFIC CORPORATIONDesara Blue TVez 3.0 — Caldera Medical, Inc.Monarc — ENDO PHARMACEUTICALS INC.Desara — Caldera Medical, Inc.GYNECARE TVT EXACT — Ethicon SàrlDesara TVez 2.7 — Caldera Medical, Inc.Align® R Retropubic Urethral Support System — C. R. Bard, Inc.Desara Blue TVez 2.7 — Caldera Medical, Inc.Monarc — ENDO PHARMACEUTICALS INC.Remeex System (for Female Urinary Incontinence) — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLGYNECARE TVT ABBREVO — Ethicon SàrlDesara TVez 3.0 — Caldera Medical, Inc.Align® TO Trans-Obturator Urethral Support System - Hook — C. R. Bard, Inc.Desara — Caldera Medical, Inc.Monarc — ENDO PHARMACEUTICALS INC.I-STOP — CL MEDICALMonarc — ENDO PHARMACEUTICALS INC.Align® RS Retropubic/Suprapubic Urethral Support System — C. R. Bard, Inc.Desara TV — Caldera Medical, Inc.GYNECARE TVT — Ethicon SàrlDesara Blue TVez 2.7 — Caldera Medical, Inc.RetroArc — ENDO PHARMACEUTICALS INC.Advantage™ System — BOSTON SCIENTIFIC CORPORATION

Recent recalls

DateFirmReason
2014-10-15American 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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.