FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K131721 |
COMED MEDICAL SYSTEMS CO., LTD |
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 |
07/22/2014 |
K111947 |
DIREX SYSTEMS CORP. |
DUET MAGNA |
03/01/2012 |
K053640 |
DIREX SYSTEMS CORP. |
INTEGRA |
03/01/2006 |
K062147 |
DIREX SYSTEMS CORP. |
INTEGRA SL |
10/20/2006 |
K041582 |
DIREX SYSTEMS CORP. |
MODIFICATION TO TRIPTER X-1 COMPACT DUET |
07/07/2004 |
K040470 |
DIREX SYSTEMS CORP. |
TRIPTER X-1 COMPACT |
04/28/2004 |
K023535 |
DIREX SYSTEMS CORP. |
TRIPTER X-1 COMPACT DUET |
01/17/2003 |
K050091 |
DIREX SYSTEMS CORP. |
TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) |
03/16/2005 |
K011773 |
DORNIER |
DORNIER LITHOTRIPTER 140(DOLI 140) |
06/22/2001 |
K011873 |
DORNIER |
DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP) |
08/31/2001 |
K170122 |
Dornier MedTech America |
Delta III Lithotripter |
06/28/2017 |
K132672 |
DORNIER MEDTECH AMERICA |
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER |
09/23/2013 |
K151298 |
Dornier MedTech America |
Gemini XXP-HP |
07/30/2015 |
K221903 |
Dornier MedTech America, Inc |
Delta III Pro |
02/22/2023 |
K172084 |
Dornier MedTech America, Inc. |
Delta III Lithotripter |
08/08/2017 |
K201074 |
Dornier MedTech America, Inc. |
Delta III Lithotripter |
09/03/2020 |
K002929 |
DORNIER MEDTECH AMERICA, INC. |
DORNIER COMPACT ALPHA LITHOTRIPTER |
04/17/2001 |
K121656 |
DORNIER MEDTECH AMERICA, INC. |
GEMINI LITHOTRIPTER |
09/24/2012 |
K130729 |
DORNIER MEDTECH SYSTEMS |
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER |
05/14/2013 |
K013471 |
E.S.W.L. PRODUCTS, INC. |
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER |
04/29/2002 |
K003529 |
EDAP TECHNOMED, INC. |
SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS |
02/12/2001 |
K111808 |
EDAP TMS FRANCE |
SONOLITH I-MOVE |
08/01/2011 |
K101482 |
ELITE MEDICAL INC |
EM-9000 |
03/31/2011 |
K030346 |
FMD, LLC |
TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER |
05/02/2003 |
K042561 |
FMD, LLC |
TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER |
10/12/2004 |
K042427 |
GENEMED, INC. |
GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER |
12/03/2004 |
K012785 |
HEALTH TRONICS SURGICAL SERVICES, INC. |
TWINTRODE ELC 134 ELECTRODE |
11/16/2001 |
K021775 |
HEALTHTRONICS, INC. |
LTFS230 |
12/23/2002 |
K040741 |
HMT HIGH MEDICAL TECHNOLOGIES AG |
ULTRASOUND LOCALIZATION SYSTEM ULS 0142 |
08/19/2004 |
K011700 |
KARL STORZ ENDOSCOPY |
MODULITH SLK LITHOTRIPTER |
08/16/2002 |
K201001 |
KARL STORZ Endoscopy America |
Modulith SLX-F2 |
03/30/2021 |
K120769 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
MODULTH SLK |
06/12/2012 |
K072788 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
STORZ MODULITH LITHOTRIPTER SLX-F2-F180 |
12/26/2007 |
K012482 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION |
10/16/2001 |
K040476 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
STORZ MODULITH, MODEL SLX-F2 |
08/26/2004 |
K070579 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
STORZ SLX-F2 STORM TOUCH |
08/30/2007 |
K010340 |
KARL STORZ LITHOTRIPSY-AMERICA, INC. |
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI |
02/13/2001 |
K103217 |
LITE-MED INC |
LITE-MED LM-9200 ELMA |
09/28/2011 |
K142561 |
LITE-MED INC. |
LM-9300 ELMA Lithotripter |
03/20/2015 |
K213772 |
Lite-Med Inc. |
LM-9300 Plus Lithotripter |
01/19/2023 |
K002801 |
MEDICAL PHYSICS AND SERVICES, INC. |
MPS M ELECTRODE |
05/04/2001 |
K040461 |
MEDISPEC, LTD. |
ECONOLITH E3000, MODEL 3000 (SW-6) |
05/25/2004 |
K063504 |
MEDISPEC, LTD. |
ECONOLITH EM1000 |
03/09/2007 |
K010900 |
MEDSTONE INTL., INC. |
STS-T LITHOTRIPTER, MODEL STS-T |
04/05/2001 |
K131817 |
OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. |
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER |
09/26/2014 |
K061350 |
PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. |
LITHODIAMOND ULTRA |
12/22/2006 |
K011106 |
PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD |
STONELITH, MODEL V5 |
02/11/2002 |
K070799 |
SIEMENS MEDICAL SOLUTIONS USA INC. |
MODULARIS VARIOSTAR |
11/01/2007 |
K070665 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
LITHOSKOP |
01/04/2008 |
K083614 |
TECHNOMED MEDICAL SYSTEMS, SA |
SONOLITH I-SYS LITHOTRIPER |
07/27/2009 |
K062081 |
TISSUE REGENERATION TECHNOLOGIES, INC. |
LITHOGOLD |
11/02/2006 |
K032958 |
UNITED MEDICAL SYSTEMS, INC. |
PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 |
02/17/2004 |
K072538 |
UNITED MEDICAL SYSTEMS, INC. |
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER |
01/30/2008 |