Panels › Gastroenterology, Urology › Product code LNS · Class 2
Lithotriptor, Extracorporeal Shock-Wave, Urological
Regulation 876.5990
2510(k)s in 12 months (56 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LNS
| Company | 510(k)s | Recalls |
|---|---|---|
| Dornier Medtech America | 8 | 0 |
| Direx Systems Corp. | 7 | 0 |
| KARL STORZ Endoscopy-America, Inc. | 6 | 0 |
| Lite-Med, Inc. | 3 | 0 |
| Siemens Medical Solutions USA, Inc. | 2 | 1 |
| Dornier | 2 | 0 |
| Fmd, LLC | 2 | 0 |
| Medispec, Ltd. | 2 | 0 |
| Sonomotion, Inc. | 2 | 0 |
| United Medical Systems, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2015 | Siemens Medical Solutions USA, Inc MODULARIS VARIOSTAR; Lithotripter device designed to treat urolithiasis. Terminated |
LNS | K070799 |
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