FDA 510(k) Applications for Medical Device:
Lithotriptor, Extracorporeal Shock-Wave,Urological
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K131721 | COMED MEDICAL SYSTEMS CO., LTD |
11874 SOUTH EVELYN CIRCLE | HOUSTON | TX | 77071 |
| K111947 | DIREX SYSTEMS CORP. |
437 TURNPIKE ST. | CANTON | MA | 02021 |
| K053640 | DIREX SYSTEMS CORP. |
437 TURNPIKE ST. | CANTON | MA | 02021 |
| K062147 | DIREX SYSTEMS CORP. |
437 TURNPIKE ST. | CANTON | MA | 02021 |
| K041582 | DIREX SYSTEMS CORP. |
11 MERCER RD. | NATICK | MA | 01760 |
| K040470 | DIREX SYSTEMS CORP. |
11 MERCER RD. | NATICK | MA | 01760 |
| K023535 | DIREX SYSTEMS CORP. |
11 MERCER RD. | NATICK | MA | 01760 |
| K050091 | DIREX SYSTEMS CORP. |
11 MERCER RD. | NATICK | MA | 01760 |
| K011773 | DORNIER |
1155 ROBERTS BLVD. | KENNESAW | GA | 30144 |
| K011873 | DORNIER |
1155 ROBERTS BLVD. | KENNESAW | GA | 30144 |
| K170122 | Dornier MedTech America |
1155 Roberts blvd | Kennesaw | GA | 30144 |
| K132672 | DORNIER MEDTECH AMERICA |
1155 ROBERTS BLVD. | KENNESAW | GA | 30144 |
| K151298 | Dornier MedTech America |
1155 Roberts Blvd | Kennesaw | GA | 30144 |
| K221903 | Dornier MedTech America, Inc |
1155 Roberts Blvd | Kennesaw | GA | 30144 |
| K172084 | Dornier MedTech America, Inc. |
1155 Roberts Blvd | Kennesaw | GA | 30144 |
| K201074 | Dornier MedTech America, Inc. |
1155 Roberts Blvd, Suite 100 | Kennesaw | GA | 30144 |
| K002929 | DORNIER MEDTECH AMERICA, INC. |
1155 ROBERTS BLVD. | KENNESAW | GA | 30144 |
| K121656 | DORNIER MEDTECH AMERICA, INC. |
1155 ROBERTS BLVD. | KENNESAW | GA | 30144 |
| K130729 | DORNIER MEDTECH SYSTEMS |
1155 ROBERTS BLVD | KENNESAW | GA | 30144 |
| K013471 | E.S.W.L. PRODUCTS, INC. |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K003529 | EDAP TECHNOMED, INC. |
100 PINNACLE WAY | NORCROSS | GA | 30071 |
| K111808 | EDAP TMS FRANCE |
COLUMBIA SQUARE 555 | WASHINGTON | DC | 20004 |
| K101482 | ELITE MEDICAL INC |
4343 SHALLOWFORD ROAD | ATLANTA | GA | 30062 |
| K030346 | FMD, LLC |
P.O. BOX 3515 | REDMOND | WA | 98073-3515 |
| K042561 | FMD, LLC |
P.O. BOX 1500 | LORTON | VA | 22199-1500 |
| K042427 | GENEMED, INC. |
660 MAIN STREET SOUTH | WOODBURY | CT | 06798 |
| K012785 | HEALTH TRONICS SURGICAL SERVICES, INC. |
1841 WEST OAK PARKWAY, SUITE A | MARIETTA | GA | 30062 |
| K021775 | HEALTHTRONICS, INC. |
1841 WEST OAK PKWY. | MARIETTA | GA | 30062 |
| K040741 | HMT HIGH MEDICAL TECHNOLOGIES AG |
719 A STREET, NE | WASHINGTON | DC | 20002 |
| K011700 | KARL STORZ ENDOSCOPY |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K201001 | KARL STORZ Endoscopy America |
2151 E Grand Avenue | El Segundo | CA | 90245 |
| K120769 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
2151 E. GRAND AVE. | EL SEGUNDO | CA | 90245 |
| K072788 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K012482 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K040476 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K070579 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K010340 | KARL STORZ LITHOTRIPSY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230 |
| K103217 | LITE-MED INC |
9TH FLOOR, 49 DONGXING ROAD | TAIPEI CITY | 110 | |
| K142561 | LITE-MED INC. |
9TH FLOOR, 49 DONGXING ROAD, XINYI DISTRICT | TAIPEI | 11070 | |
| K213772 | Lite-Med Inc. |
9th Floor, 49 Dongxing Road, Xinyi District | Taipei | 11070 | |
| K002801 | MEDICAL PHYSICS AND SERVICES, INC. |
1091 IRMA DRIVE, UNIT C | DENVER | CO | 80233 |
| K040461 | MEDISPEC, LTD. |
12850 MIDDLEBROOK RD. STE. 1 | GERMANTOWN | MD | 20874 |
| K063504 | MEDISPEC, LTD. |
12850 MIDDLEBROOK RD. STE. 1 | GERMANTOWN | MD | 20874 |
| K010900 | MEDSTONE INTL., INC. |
100 COLUMBIA, SUITE 100 | ALISO VIEJO | CA | 92656-4114 |
| K131817 | OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. |
NO. 982 COGYUN ROAD | GUANGZHOU, GUANGDONG | 510420 | |
| K061350 | PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004 |
| K011106 | PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD |
59/1 SANCAK, CANKAYA | ANKARA | 06550 | |
| K242922 | Shenzhen Wikkon Precision Technologies Co., Ltd. |
Room 1503, 15th Floor, Building A, Chuanglingtong Science | Shenzhen | 518026 | |
| K070799 | SIEMENS MEDICAL SOLUTIONS USA INC. |
51 VALLEY STREAM PARKWAY | MALVERN | PA | 19355 |
| K070665 | SIEMENS MEDICAL SOLUTIONS USA, INC. |
51 VALLEY STREAM PKWY. | MALVERN | PA | 19355 |
| K083614 | TECHNOMED MEDICAL SYSTEMS, SA |
106 EAST 5TH AVENUE | MOUNT DORA | FL | 32757 |
| K062081 | TISSUE REGENERATION TECHNOLOGIES, INC. |
719 A ST., NE | WASHINGTON | DC | 20002 |
| K032958 | UNITED MEDICAL SYSTEMS, INC. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004-1109 |
| K072538 | UNITED MEDICAL SYSTEMS, INC. |
700 THIRTEENTH STREET NW | WASHINGTON | DC | 20005 |
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