Rongeur, Manual
Regulation 882.4840
1510(k)s in 12 months (37 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in HAE
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxano, Inc. | 6 | 0 |
| Morpheus AG | 3 | 0 |
| Folsom Metal Products, Inc. | 0 | 2 |
| Integra Lifesciences Corp. | 2 | 0 |
| Symmetry Surgical | 2 | 0 |
| Von Zeppelin GmbH | 2 | 0 |
| Ace Medical | 1 | 0 |
| Aesculap, Inc. | 1 | 0 |
| Dannoritzer Medical Instruments | 1 | 0 |
| Enterprise Medical Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2024 | Folsom Metal Products, Inc. Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing:
1. DKS Small Obturator Trocar (Model Number 330.013)
2. DKs Small Open, Classified |
HAE | None listed |
| Dec 6, 2024 | Folsom Metal Products, Inc. DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing:
1. DKS Large Obturator Trocar (Model Number 330.017)
2. DKS Large Light Open, Classified |
HAE | None listed |
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