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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 22, 2001 | K011773 | DORNIER LITHOTRIPTER 140(DOLI 140) Dornier | LNS |
| May 4, 2001 | K002801 | MPS M ELECTRODE Medical Physics and Services, Inc. | LNS |
| Apr 17, 2001 | K002929 | DORNIER COMPACT ALPHA LITHOTRIPTER Dornier Medtech America, Inc. | LNS |
| Apr 5, 2001 | K010900 | STS-T LITHOTRIPTER, MODEL STS-T Medstone Intl., Inc. | LNS |
| Feb 13, 2001 | K010340 | MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI Karl Storz Lithotripsy-America, Inc. | LNS |
| Feb 12, 2001 | K003529 | SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS Edap Technomed, Inc. | LNS |
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