Panels › Gastroenterology, Urology › Product code FFO · Class 1
Retractor, Self-Retaining
Regulation 876.4730
0510(k)s in 12 months (5 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in FFO
| Company | 510(k)s | Recalls |
|---|---|---|
| Abeon Medical Corporation | 0 | 2 |
| Dantec Electronics, Inc. | 2 | 0 |
| Advanced Surgical Concepts (Asc) | 1 | 0 |
| The Kendal Co. | 1 | 0 |
| Sklar Instruments | 0 | 1 |
| Sur-Med Instruments, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 1999 | K993544 | SPACE-OR RETRACTOR Advanced Surgical Concepts (Asc) | FFO |
| Jun 4, 1987 | K870897 | KODNER ANAL PERIONEAL RETRACTOR Sur-Med Instruments, Inc. | FFO |
| Apr 23, 1986 | K860368 | URDYN 5000 (UROFLOWMETER) Dantec Electronics, Inc. | FFO |
| Oct 4, 1985 | K853119 | URODYN 1000 Dantec Electronics, Inc. | FFO |
| Sep 20, 1985 | K852083 | THE KENDALL URINARY OUTPUT MONITOR The Kendal Co. | FFO |
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