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I-STOP TOMS

CL MEDICAL · Model IS-TOMS-1 · UDI-DI 03760151650239

OTM
1
510(k) clearances
1,516
Adverse events (6 deaths)
1
Recalls
12
Facilities

Description

Sling for male incontinence

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 Passer components s

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.