| Break Wave (K261086) | Sonomotion, Inc. | 2026-04-29 |
| Break Wave (K252913) | Sonomotion, Inc. | 2026-01-12 |
| Extracorporeal Shock Wave Lithotripter (U200) (K242922) | Shenzhen Wikkon Precision Technologies Co., Ltd. | 2025-06-18 |
| Delta III Pro (K221903) | Dornier Medtech America, Inc. | 2023-02-22 |
| LM-9300 Plus Lithotripter (K213772) | Lite-Med, Inc. | 2023-01-19 |
| Modulith SLX-F2 (K201001) | Karl Storz Endoscopy America | 2021-03-30 |
| Delta III Lithotripter (K201074) | Dornier Medtech America, Inc. | 2020-09-03 |
| Delta III Lithotripter (K172084) | Dornier Medtech America, Inc. | 2017-08-08 |
| Delta III Lithotripter (K170122) | Dornier Medtech America | 2017-06-28 |
| Gemini XXP-HP (K151298) | Dornier Medtech America | 2015-07-30 |
| LM-9300 ELMA Lithotripter (K142561) | Lite-Med, Inc. | 2015-03-20 |
| EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K131817) | Osmunda Medical Device Consulting Co., Ltd. | 2014-09-26 |
| EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 (K131721) | Comed Medical Systems Co., Ltd. | 2014-07-22 |
| EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER (K132672) | Dornier Medtech America | 2013-09-23 |
| EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER (K130729) | Dornier Medtech Systems | 2013-05-14 |
| GEMINI LITHOTRIPTER (K121656) | Dornier Medtech America, Inc. | 2012-09-24 |
| MODULTH SLK (K120769) | KARL STORZ Endoscopy-America, Inc. | 2012-06-12 |
| DUET MAGNA (K111947) | Direx Systems Corp. | 2012-03-01 |
| LITE-MED LM-9200 ELMA (K103217) | Lite-Med, Inc. | 2011-09-28 |
| SONOLITH I-MOVE (K111808) | Edap Tms France | 2011-08-01 |
| EM-9000 (K101482) | Elite Medical, Inc. | 2011-03-31 |
| SONOLITH I-SYS LITHOTRIPER (K083614) | Technomed Medical Systems, SA | 2009-07-27 |
| PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER (K072538) | United Medical Systems, Inc. | 2008-01-30 |
| LITHOSKOP (K070665) | Siemens Medical Solutions USA, Inc. | 2008-01-04 |
| STORZ MODULITH LITHOTRIPTER SLX-F2-F180 (K072788) | KARL STORZ Endoscopy-America, Inc. | 2007-12-26 |
| MODULARIS VARIOSTAR (K070799) | Siemens Medical Solutions USA, Inc. | 2007-11-01 |
| STORZ SLX-F2 STORM TOUCH (K070579) | KARL STORZ Endoscopy-America, Inc. | 2007-08-30 |
| ECONOLITH EM1000 (K063504) | Medispec, Ltd. | 2007-03-09 |
| LITHODIAMOND ULTRA (K061350) | Pck Electronic Industry & Trade Co., Ltd. | 2006-12-22 |
| LITHOGOLD (K062081) | Tissue Regeneration Technologies, Inc. | 2006-11-02 |
| INTEGRA SL (K062147) | Direx Systems Corp. | 2006-10-20 |
| INTEGRA (K053640) | Direx Systems Corp. | 2006-03-01 |
| TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) (K050091) | Direx Systems Corp. | 2005-03-16 |
| GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K042427) | Genemed, Inc. | 2004-12-03 |
| TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K042561) | Fmd, LLC | 2004-10-12 |
| STORZ MODULITH, MODEL SLX-F2 (K040476) | KARL STORZ Endoscopy-America, Inc. | 2004-08-26 |
| ULTRASOUND LOCALIZATION SYSTEM ULS 0142 (K040741) | Hmt High Medical Technologies AG | 2004-08-19 |
| MODIFICATION TO TRIPTER X-1 COMPACT DUET (K041582) | Direx Systems Corp. | 2004-07-07 |
| ECONOLITH E3000, MODEL 3000 (SW-6) (K040461) | Medispec, Ltd. | 2004-05-25 |
| TRIPTER X-1 COMPACT (K040470) | Direx Systems Corp. | 2004-04-28 |
| PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 (K032958) | United Medical Systems, Inc. | 2004-02-17 |
| TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER (K030346) | Fmd, LLC | 2003-05-02 |
| TRIPTER X-1 COMPACT DUET (K023535) | Direx Systems Corp. | 2003-01-17 |
| LTFS230 (K021775) | Healthtronics, Inc. | 2002-12-23 |
| MODULITH SLK LITHOTRIPTER (K011700) | Karl Storz Endoscopy | 2002-08-16 |
| DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER (K013471) | E.S.W.L. Products, Inc. | 2002-04-29 |
| STONELITH, MODEL V5 (K011106) | Pck Electronic Industry and Trade Co, Ltd. | 2002-02-11 |
| TWINTRODE ELC 134 ELECTRODE (K012785) | Healthtronics Surgical Services, Inc. | 2001-11-16 |
| STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION (K012482) | KARL STORZ Endoscopy-America, Inc. | 2001-10-16 |
| DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP) (K011873) | Dornier | 2001-08-31 |
| DORNIER LITHOTRIPTER 140(DOLI 140) (K011773) | Dornier | 2001-06-22 |
| MPS M ELECTRODE (K002801) | Medical Physics and Services, Inc. | 2001-05-04 |
| DORNIER COMPACT ALPHA LITHOTRIPTER (K002929) | Dornier Medtech America, Inc. | 2001-04-17 |
| STS-T LITHOTRIPTER, MODEL STS-T (K010900) | Medstone Intl., Inc. | 2001-04-05 |
| MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (K010340) | Karl Storz Lithotripsy-America, Inc. | 2001-02-13 |
| SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS (K003529) | Edap Technomed, Inc. | 2001-02-12 |