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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A;
2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A Open, Classified |
FFO | None listed |
| Nov 25, 2015 | Abeon Medical Corporation TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA)
Indicated to aid in tissue retraction during a surgical procedure. Terminated |
FFO | None listed |
| Nov 25, 2015 | Abeon Medical Corporation TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY.
Indicated for use in the retraction of soft tissue away from the operative surface. Terminated |
FFO | None listed |
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