FDA 510(k) Applications for Medical Device:
Instrument, Ultrasonic Surgical
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K101561 | AMERICAN OPTISURGICAL, INC. |
25501 ARCTIC OCEAN | LAKE FOREST | CA | 92630 |
| K031523 | AOMORI OLYMPUS CO., LTD. |
2 CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K031710 | AOMORI OLYMPUS CO., LTD. |
2 CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K042160 | AOMORI OLYMPUS CO., LTD. |
2 CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K041566 | AOMORI OLYMPUS CO., LTD. |
2 CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K062544 | AROBELLA MEDICAL, LLC |
11460 N. MERIDIAN STREET | CARMEL | IN | 46032 |
| K021929 | AXYA MEDICAL, INC. |
100 CUMMINGS CENTER | BEVERLY | MA | 01915 |
| K964742 | AZIZ Y. ANIS, M.D. |
9327 BLACKLEY | TEMPLE CITY | CA | 91780 |
| K980895 | CALIFORNIA INSTITUTE OF TISSUE ENG. & INSTRUMENTI |
205 SOUTH WEST ST., SUITE A | VISALIA | CA | 93291 |
| K153371 | COVIDIEN LLC |
5920 LONGBOW DRIVE | BOULDER | CO | 80301 |
| K101797 | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO |
5920 LONGBOW DRIVE | BOULDER | CO | 80301 |
| K141371 | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
5920 Longbow Dr | BOULDER | CO | 80301 |
| K212301 | Covidien, LLC |
5920 Longbow Dr. | Boulder | CO | 80301 |
| K200427 | Covidien, llc |
5920 Longbow Dr. | Boulder | CO | 80301 |
| K180149 | Covidien, llc |
5920 Longbow Drive | Boulder | CO | 80301 |
| K150271 | ENDOPRIME, INC. |
4480 LAKE FOREST DRIVE, SUITE 412 | CINCINNATI | OH | 45242 |
| K160752 | ETHICON ENDO-SUREGERY, LLC |
475 CALLE C | GUAYNABO | PR | 00969 |
| K042777 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K051036 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K053056 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242 |
| K060245 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K062000 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K980099 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K962584 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K983316 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K971302 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K012176 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K010898 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K993054 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K990430 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K994280 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K002906 | ETHICON ENDO-SURGERY, INC. |
4545 CREEK RD. | CINCINNATI | OH | 45242-2839 |
| K072203 | ETHICON ENDO-SURGERY, LLC |
4545 CREEK RD. | CINCINNATI | OH | 45242 |
| K221790 | Ethicon Endo-Surgery, LLC |
475 Calle C | Guaynabo | PR | 00969 |
| K132522 | ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD | CINCINNATI | OH | 45242 |
| K132512 | ETHICON ENDO-SURGERY, LLC |
4545 CREEK RD. | CINCINNATI | OH | 45242 |
| K121550 | ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD | CINCINNATI | OH | 45242 |
| K132612 | ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD | CINCINNATI | OH | 45242 |
| K063192 | ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD | CINCINNATI | OH | 45242 |
| K151340 | ETHICON ENDO-SURGERY, LLC |
475 CALLE C | GUAYNABO | PR | 00969 |
| K100597 | ETHICON ENDO-SURGERY, LLC |
4545 CREEK RD. | CINCINNATI | OH | 45242 |
| K133314 | ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD | CINCINNATI | OH | 45242 |
| K211273 | Ethicon Endo-Surgery, LLC |
475 Calle C | Guaynabo | PR | 00969 |
| K191555 | Ethicon Endo-Surgery, LLC |
475 Calle C | Guaynabo | PR | 00969 |
| K151136 | ETHICON ENDO-SURGERY, LLC |
475 CALLE C | GUAYNABO | PR | 00969 |
| K120729 | ETHICON ENDO-SURGERY, LLC |
4545 CREEK ROAD | CINCINNATI | OH | 45242 |
| K983199 | FIBRA SONICS, INC. |
5312 N. ELSTON AVE. | CHICAGO | IL | 60630 |
| K980930 | FIBRA SONICS, INC. |
5312 N. ELSTON AVE. | CHICAGO | IL | 60630 |
| K113570 | INTEGRA BURLINGTON MA, INC. |
22 TERRY AVE. | BURLINGTON | MA | 01803 |
| K111741 | INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI |
22 Terry Ave | BURLINGTON | MA | 01803 |
| K150682 | INTEGRA LIFESCIENCES CORP. |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08536 |
| K200774 | Integra LifeSciences Corporation |
1100 Campus Rd | Princeton | NJ | 08540 |
| K221763 | Integra LifeSciences Corporation |
1100 Campus Rd | Princeton | NJ | 08540 |
| K230427 | Integra Lifesciences Corporation |
1100 Campus Rd | Princeton | NJ | 08540 |
| K221835 | Integra Lifesciences Corporation |
1100 Campus Road | Princeton | NJ | 08540 |
| K161882 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DRIVE | PLAINSBORO | NJ | 08536 |
| K182809 | Integra LifeSciences Corporation |
311 Enterprise Drive | Plainsboro | NJ | 08536 |
| K190180 | Integra LifeSciences Corporation |
311 Enterprise Drive | Plainsboro | NJ | 08536 |
| K141668 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08535 |
| K141674 | INTEGRA LIFESCIENCES CORPORATION |
311 ENTERPRISE DR. | PLAINSBORO | NJ | 08535 |
| K172595 | Integra LifeSciences Corporation |
311 Enterprise Drive | PLAINSBORO | NJ | 08536 |
| K021989 | INTEGRA NEUROSCIENCES |
5955 PACIFIC CENTER BLVD. | SAN DIEGO | CA | 92121 |
| K042277 | INTEGRA NEUROSCIENCES, LTD. |
NEWBURY RD. | ANDOVER HAMPSHIRE | SP10 4DR | |
| K090864 | INTEGRA RADIONICS, INC. |
22 TERRY AVENUE | BURLINGTON | MA | 01803 |
| K102258 | INTEGRA RADIONICS, INC. |
22 TERRY AVENUE | BURLINGTON | MA | 01803 |
| K081459 | INTEGRA RADIONICS, INC. |
22 TERRY AVENUE | BURLINGTON | MA | 01803 |
| K071669 | INTEGRA RADIONICS, INC. |
22 TERRY AVENUE | BURLINGTON | MA | 01803 |
| K192963 | Katalyst Surgical, LLC |
754 Goddard Avenue | Chesterfield | MO | 63005 |
| K070360 | KIRWAN SURGICAL PRODUCTS, INC. |
180 ENTERPRISE DR. | MARSHFIELD | MA | 02050 |
| K972148 | MEDICAMAT S.A. |
1776 K STREET, N.W. | WASHINGTON | DC | 20006 |
| K190281 | MediSonic Technology Co |
11411 Southern Highlands Parkway, Suite 300 | Las Vegas | NV | 89141 |
| K970471 | MENTOR CORP. |
5425 HOLLISTER AVE. | SANTA BARBARA | CA | 93111 |
| K983065 | MENTOR CORP. |
5425 HOLLISTER AVE. | SANTA BARBARA | CA | 93111 |
| K210567 | Miconvey Technologies Co., Ltd. |
No.16 Fangzheng Avenue, Beibei District | Chongqing | 400714 | |
| K212060 | Misonix Inc. |
1938 New Highway | Farmingdale | NY | 11735 |
| K221235 | Misonix Inc. |
1938 New Highway | Farmingdale | NY | 11735 |
| K000927 | MISONIX, INC. |
1938 NEW HIGHWAY | FARMINGDALE | NY | 11735 |
| K012028 | MISONIX, INC. |
1938 NEW HIGHWAY | FARMINGDALE | NY | 11735 |
| K050776 | MISONIX, INC. |
1938 NEW HIGHWAY | FARMINGDALE | NY | 11735 |
| K032690 | MISONIX, INC. |
1938 NEW HIGHWAY | FARMINGDALE | NY | 11735 |
| K070313 | MISONIX, INC. |
1938 NEW HIGHWAY | FARMINGDALE | NY | 11735 |
| K982841 | MISONIX, INC. |
55 NORTHERN BLVD., SUITE 200 | GREAT NECK | NY | 11021 |
| K190160 | Misonix, Inc. |
1938 New Highway | Farmingdale | NY | 11735 |
| K062471 | MISONIX, INC. |
1938 NEW HIGHWAY | FARMINGDALE | NY | 11735 |
| K231117 | Misonix, LLC, a Bioventus Company |
1938 New Highway | Farmingdale | NY | 11735 |
| K962525 | MORWEL CORP. |
8000 SOUTH KOLB RD. | TUCSON | AZ | 85706 |
| K010309 | MUTOH AMERICA CO., LTD. |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K172691 | OLYMPUS MEDICAL SYSTEMS CORP. |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K050885 | OLYMPUS MEDICAL SYSTEMS CORPORATION |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K211838 | Olympus Medical Systems Corporation |
2951 Ishikawa-cho | Hachioji-shi | 192-8507 | |
| K031305 | OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. | MELVILLE | NY | 11747-3157 |
| K993628 | OMNISONICS MEDICAL TECHNOLOGIES |
7 TIFFANY TRAIL | HOPKONTON | MA | 01748 |
| K003824 | OMNISONICS MEDICAL TECHNOLOGIES |
66 CONCORD STREET, SUITE A | WILMINGTON | MA | 01887 |
| K051947 | RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
22 TERRY AVE. | BURLINGTON | MA | 01803 |
| K971609 | SERVIZI MEDICO ESTETICI ITALINAI SRL. |
15 VIA F. NEGRI | CASALE MONFERRATO (AL) | ||
| K960040 | SHARPLAN LASERS, INC. |
1 PEARL COURT | ALLENDALE | NJ | 07401 |
| K202299 | SMTP Technology Co., Ltd |
1F&4F, Building A, Emerging Industry Incubation Center | Zhangjiagang | 215634 | |
| K212750 | SMTP Technology Co., Ltd. |
1F&4F, Building A, Emerging Industry Incubation Center | Zhangjiagang | 215634 | |
| K072904 | SOERING GMBH |
1600 MANCHESTER WAY | CORINTH | TX | 76210 |
| K971533 | SONICS & MATERIALS, INC. |
KENOSIA AVE. | DANBURY | CT | 06810 |
| K990572 | SONOKINETICS, INC. |
7 TIFFANY TRAIL | HOPKINTON | MA | |
| K012753 | SORING GMBH MEDIZINTECHNIK |
1100 LAKEVIEW BLVD. | DENTON | TX | 76208 |
| K991791 | SOUND SURGICAL TECHNOLOGIES LLC. |
1300 PLAZA CT. NORTH, #203 | LAFAYETTE | CO | 80026 |
| K993868 | SOUND SURGICAL TECHNOLOGIES LLC. |
1300 PLAZA CT. NORTH, #203 | LAFAYETTE | CO | 80026 |
| K221102 | SRA Developments Ltd |
Bremridge House | Ashburton | TQ13 7JX | |
| K032424 | SRA DEVELOPMENTS, LTD. |
2305 GOLD MINE ROAD | BROOKEVILLE | MD | 20833 |
| K151101 | SRA DEVELOPMENTS, LTD. |
BREMRIDGE HOUSE | ASHBURTON, DEVON | TQ13 7JX | |
| K063531 | SRA DEVELOPMENTS, LTD. |
BREMRIDGE HOUSE | ASHBURTON, DEVON | TQ13 7JX | |
| K223770 | Stryker Corporation |
1941 Stryker Way | Kalamazoo | MI | 49002 |
| K190070 | Stryker Corporation |
4100 E. Milham Ave. | Kalamazoo | MI | 49001 |
| K213824 | Stryker Corporation |
4100 East Milham Ave. | Kalamazoo | MI | 49001 |
| K212614 | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
No.1 XinXing Yilu Road, Emerging Industrial Cluster Area | Cixi | 315301 | |
| K010637 | SYNERGETICS, INC. |
88 HUBBLE DR. | ST. CHARLES | MO | 63304-8694 |
| K020220 | SYNERGETICS, INC. |
88 HUBBLE DR. | ST. CHARLES | MO | 63304-8694 |
| K212049 | TendoNova Corporation |
3050 Business Park Drive, Suite A-2 | Norcross | GA | 30071 |
| K123640 | TENEX HEALTH |
26902 VISTA TERRACE | LAKE FOREST | CA | 92630 |
| K153299 | TENEX HEALTH, INC. |
26902 VISTA TERRACE | LAKE FOREST | CA | 92630 |
| K181367 | Tenex Health, Inc. |
26902 Vista Terrace | Lake Forest, | CA | 92630 |
| K972114 | THE OLYMPUS OPTICAL CO. |
55 NORTHERN BLVD. | GREAT NECK | NY | 11021 |
| K000095 | THE OLYMPUS OPTICAL CO. |
TWO CORPORATE DR. | MELVILLE | NY | 11747 |
| K021962 | THE OLYMPUS OPTICAL CO. |
TWO CORPORATE DR. | MELVILLE | NY | 11747 |
| K032066 | THE OLYMPUS OPTICAL CO. |
ENDOSCOPE DIVISION | MELVILLE | NY | 11747-3157 |
| K960374 | ULTRALASE TECHNOLOGIES, INC. |
9327 BLACKLEY ST. | TEMPLE CITY | CA | 91780 |
| K971861 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K981262 | VALLEYLAB, INC. |
5920 LONGBOW DR. | BOULDER | CO | 80301 |
| K964601 | VALLEYLAB, INC. |
5920 LONGBOW DR. | BOULDER | CO | 80301 |
| K971580 | WELLS JOHNSON CO. |
8000 S. KOLB ROAD-85706 | TUCSON | AZ | 85731-8230 |
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