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Obtryx™ System - Curved
BOSTON SCIENTIFIC CORPORATION · Model M0068504000 · UDI-DI 08714729718963
OTN
Prescription
10
510(k) clearances
38,668
Adverse events (376 deaths)
1
Recalls
30
Facilities
Description
Transobturator Mid-Urethral System
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 Passer components s |
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Get your free API keyRead the docsData 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.