Panels › Gastroenterology, Urology › Product code FDG · Class 1
Retractor, Fiberoptic
Regulation 876.4530
0510(k)s in 12 months (2 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in FDG
| Company | 510(k)s | Recalls |
|---|---|---|
| Bioenterics Corp. | 1 | 0 |
| Biomet Microfixation, Inc. | 0 | 1 |
| Lumitex Inc | 0 | 1 |
| Stephen Chakoff, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 1997 | K964561 | ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA Bioenterics Corp. | FDG |
| Dec 23, 1994 | K945421 | CHAKOFF ENDOSCOPY Stephen Chakoff, Inc. | FDG |
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