Product code FAG ยท Class 3
Prosthesis, Urethral Sphincter
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FAG
| Company | 510(k)s | Recalls |
|---|---|---|
| American Medical Systems, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 18, 1992 | K912934 | AMS SPHINCTER 800 URINARY PROSTHESIS American Medical Systems, Inc. | FAG |
| Aug 10, 1982 | K821627 | THE ARTIFICIAL URINARY SPHINCTER American Medical Systems, Inc. | FAG |
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