Panels › Gastroenterology, Urology › Product code FEX · Class 1
Instrument, Catheter, Punch
Regulation 876.5090
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 FEX
| Company | 510(k)s | Recalls |
|---|---|---|
| Hgm Medical Laser Systems, Inc. | 1 | 0 |
| Xomed, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 11, 1991 | K911104 | PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 Hgm Medical Laser Systems, Inc. | FEX |
| Sep 26, 1977 | K771725 | BIOSP. TOTAL OSSICULAR REPLACE. PROSTHE. Xomed, Inc. | FEX |
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