LNS · Class II · 21 CFR 876.5990

FDA Product Code LNS: Lithotriptor, Extracorporeal Shock-wave, Urological

Leading manufacturers include Direx Systems Corp., Dornier Medtech America, Inc. and KARL STORZ Endoscopy-America, Inc..

56
Total
56
Cleared
157d
Avg days
2001
Since
56 devices
49–56 of 56
Cleared Oct 16, 2001
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Aug 31, 2001
DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
K011873
Dornier
Gastroenterology & Urology · 77d
Cleared Jun 22, 2001
DORNIER LITHOTRIPTER 140(DOLI 140)
K011773
Dornier
Gastroenterology & Urology · 15d
Cleared May 04, 2001
MPS M ELECTRODE
K002801
Medical Physics and Services, Inc.
Gastroenterology & Urology · 238d
Cleared Apr 17, 2001
DORNIER COMPACT ALPHA LITHOTRIPTER
K002929
Dornier Medtech America, Inc.
Gastroenterology & Urology · 209d
Cleared Apr 05, 2001
STS-T LITHOTRIPTER, MODEL STS-T
K010900
Medstone Intl., Inc.
Gastroenterology & Urology · 10d
Cleared Feb 13, 2001
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI
K010340
Karl Storz Lithotripsy-America, Inc.
Gastroenterology & Urology · 8d
Cleared Feb 12, 2001
SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS
K003529
Edap Technomed, Inc.
Gastroenterology & Urology · 88d