FDA 510(k) Applications for Medical Device:
Stimulator, Nerve
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971143 | AARON MEDICAL INDUSTRIES |
7100 30TH AVE. NORTH | ST. PETERSBURG | FL | 33710 |
| K152769 | AD-TECH MEDICAL INSTRUMENT CORPORATION |
1901 WILLIAM STREET | RACINE | WI | 53404 |
| K200886 | Allotrope Medical Inc |
2450 Holcombe Blvd., Suite J | Houston | TX | 77021 |
| K090838 | AXON SYSTEMS, INC. |
80-5 DAVIDS DRIVE | HAUPPAUGE | NY | 11788 |
| K081742 | BAXANO, INC. |
2660 MARINE WAY, SUITE B | MOUNTAIN VIEW | CA | 94043 |
| K092729 | BAXANO, INC. |
1171 BARROILHET AVENUE | HILLSBOROUGH | CA | 94010-6577 |
| K110696 | BAXANO, INC. |
655 RIVER OAKS PKWY | SAN JOSE | CA | 95134 |
| K233001 | Biosys Biyomedikal Muhendislik San. Ve Tic. A.S. |
Universiteler Mah. Ihsan Dogramaci Bul. Cd. Sk. No:23/C | Ankara | 06800 | |
| K103128 | CADWELL LAB, INC. |
909 NORTH KELLOGG ST. | KENNEWICK | WA | 99336 |
| K212355 | Checkpoint Surgical |
6050 Oak Tree Blvd., Suite 360 | Independence | OH | 44131 |
| K062549 | EXCEL TECH. LTD. |
2568 BRISTOL CIRCLE | OAKVILLE, ONTARIO | L6H 5S1 | |
| K021595 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K100992 | INNOVATIVE SURGICAL SOLUTIONS, LLC ("ISS") |
55 NORTHERN BLVD | GREAT NECK | NY | 10021 |
| K242852 | inomed Medizintechnik GmbH |
Im Hausgruen 29 | Emmendingen | 79312 | |
| K152505 | INOMED MEDIZINTECHNIK GMBH |
IM HAUSGRUEN 29 | EMMENDINGEN BADEN- WUERTTEMBERG | D- 79312 | |
| K223254 | Inomed Medizintechnik GmbH |
Im Hausgruen 29 | Emmendingen | 79312 | |
| K091874 | INOMED MEDIZINTECHNIK GMBH |
1468 HARWELL AVE | CROFTON | MD | 21114 |
| K212164 | inomed Medizintechnik GmbH |
Im Hausgruen 29 | Emmendingen | 79312 | |
| K122040 | INVOTEC INTERNATIONAL, INC. |
6833 PHILLIPS INDUSTRIAL BLVD. | JACKSONVILLE | FL | 32256-3029 |
| K031510 | MEDTRONIC XOMED |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K050162 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K112686 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K230320 | Medtronic Xomed, Inc. |
6743 Southpoint Drive North | Jacksonville | FL | 32216 |
| K213246 | Medtronic Xomed, Inc. |
6743 Southpoint Drive North | Jacksonville | FL | 32216 |
| K231580 | Medtronic Xomed, Inc. |
6743 Southpoint Drive North | Jacksonville | FL | 32216 |
| K063305 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K014165 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K031003 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K092292 | NDI MEDICAL LLC |
22901 MILLCREEK BOULEVARD | CLEVELAND | OH | 44122 |
| K061365 | NDI MEDICAL, LLC |
ONE CHAGRIN HIGHLANDS | CLEVELAND | OH | 44122 |
| K150005 | NDI Medical, LLC |
22901 Millcreek Boulevard, Suite 110 | Cleveland | OH | 44122 |
| K110712 | NEUROVISION MEDICAL PRODUCTS, INC. |
2225 SPERRY AVE, SUITE 1000 | VENTURA | CA | 93003 |
| K110989 | NEUROVISION MEDICAL PRODUCTS, INC. |
2225 SPERRY AVE, SUITE 1000 | VENTURA | CA | 93003 |
| K102862 | NEUROVISION MEDICAL PRODUCTS, INC. |
2225 SPERRY AVE, SUITE 1000 | VENTURA | CA | 93003 |
| K121931 | NEUROVISION MEDICAL PRODUCTS, INC. |
2225 SPERRY AVE, SUITE 1000 | VENTURA | CA | 93003 |
| K110138 | NEUROVISION MEDICAL PRODUCTS, INC. |
2225 SPERRY AVE, SUITE 1000 | VENTURA | CA | 93003 |
| K020955 | NICOLET BIOMEDICAL, INC. |
800 LEVANGER LN. | STOUGHTON | WI | 53589 |
| K111597 | NUVASIVE, INC. |
7475 LUSK BLVD | SAN DIEGO | CA | 92121 |
| K032083 | NUVASIVE, INC. |
10065 OLD GROVE RD. | SAN DIEGO | CA | 92131 |
| K040543 | NUVASIVE, INC. |
10065 OLD GROVE RD. | SAN DIEGO | CA | 92131 |
| K051718 | NUVASIVE, INC. |
4545 TOWNE CENTRE COURT | SAN DIEGO | CA | 92121 |
| K112717 | NUVASIVE, INC. |
7475 LUSK BLVD | SAN DIEGO | CA | 92121 |
| K112718 | NUVASIVE, INC. |
7475 LUSK BLVD | SAN DIEGO | CA | 92121 |
| K112709 | NUVASIVE, INCORPORATED |
7475 LUSK BOULEVARD | SAN DIEGO | CA | 92121 |
| K230853 | Nvision Biomedical Technologies, Inc. |
4590 Lockhill Selma | San Antonio | TX | 78249 |
| K241917 | Retropsoas Technologies, LLC |
34 Countryside Lane | Frontenac | MO | 63131 |
| K072736 | RHYTHMLINK INTERNATIONAL, LLC |
1256 FIRST ST. SOUTH EXTENSION | COLUMBIA | SC | 29209 |
| K112435 | RHYTHMLINK INTERNATIONAL, LLC |
1140 FIRST STREET SOUTH | COLUMBIA | SC | 29209 |
| K003745 | RLN SYSTEMS, INC. |
2019 HONEYSUCKLE LN. | JEFFERSON CITY | MO | 65109 |
| K111671 | SEASPINE, INC. |
2302 LA MIRADA DR. | VISTA | CA | 92081-7862 |
| K093373 | SPES MEDICA S.R.L. |
VIA EUROPA-ZONA INDUSTRIALE | BATTIPAGLIA | 84091 | |
| K133348 | SPES MEDICA S.R.L. |
VIA EUROPA-ZONA INDUSTRIALE | BATTIPAGLIA | 84091 | |
| K140400 | STRYKER CORPORATION |
2 PEARL COURT | ALLENDALE | NJ | 07401 |
| K232888 | Suzhou Haishen Medical Device Associates Co., Ltd |
3F, 4F (Room 401, 402), 5F, Building 10, No. 168, Majian Rd | Suzhou | 215000 | |
| K121257 | TECHNOMED EUROPE |
AMERIKALAAN 71 | MAASTRICHT AIRPORT | 6199 AE | |
| K110422 | TECHNOMED EUROPE |
AMERIKALAAN 71 | MAASTRICHT AIRPORT | 6199 AE | |
| K991583 | THE MAGSTIM COMPANY LTD. |
730 FIFTH AVE, 9TH FLOOR | NEW YORK | NY | 10019 |
| K964869 | THE MAGSTIM COMPANY LTD. |
SPRING GARDENS, WHITLAND | DYFED, WALES | SA34 OHR | |
| K980148 | THE MAGSTIM COMPANY LTD. |
SPRING GARDENS, WHITLAND | DYFED, WALES | SA34 OHR | |
| K083242 | THE MAGSTIM COMPANY LTD. |
SPRING GARDENS | CARMARTHENSHIRE, WALES | SA34 OHR | |
| K071349 | THE MAGSTIM COMPANY LTD. |
SPRING GARDENS | CARMARTHENSHIRE, WALES | SA34 OHR | |
| K053141 | THE MAGSTIM COMPANY LTD. |
SPRING GARDENS | WHITLAND, DYFED WALES | SA34 OHR | |
| K000507 | UROMED CORP. |
1400 PROVIDENCE HWY. | NORWOOD | MA | 02062 |
| K010213 | UROMED CORP. |
1400 PROVIDENCE HWY. | NORWOOD | MA | 02062 |
| K970971 | UROMED CORP. |
64 A ST. | NEEDHAM | MA | 02194 |
| K063560 | WR MEDICAL ELECTRONICS CO. |
800 LAVANGER LANE | STOUGHTON | WI | 53589 |
| K112426 | XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. |
JIANXIANG YUAN #209 | HAIDIAN DIS., BEIJING | 100083 | |
| K982595 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
| K992869 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
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