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Mesh, Surgical, For Stress Urinary Incontinence, Male

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

12

Registered devices

1,516

Adverse events

1

Recalls

12

510(k) clearances

Devices with this code

Remeex System - Passer Handle — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL Male Remeex System — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL Virtue — Coloplast A/S AdVance — AMERICAN MEDICAL SYSTEMS, INC.Remeex System -Readjustment kit Long — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL AdVance — AMERICAN MEDICAL SYSTEMS, INC.Male Remeex System - Thread Passer — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL AdVance™ XP — BOSTON SCIENTIFIC CORPORATION AdVance™ XP — BOSTON SCIENTIFIC CORPORATION Male Remeex System - Readjustment kit — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL AdVance — AMERICAN MEDICAL SYSTEMS, INC.I-STOP TOMS — CL MEDICAL

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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.