FDA 510(k) Applications for Medical Device:
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K221184 | Bien-Air Surgery SA |
Rue de l'Ouest 2b | Le Noirmont | 2340 | |
| K083720 | BIEN-AIR SURGERY SA |
RUE DE L'OUEST 2B | LE NOIRMONT | 2340 | |
| K143492 | Bien-Air Surgery SA |
Rue de l'Ouest 2b | Le Noirmont | 2340 | |
| K161376 | Grace Medical, Inc. |
8500 Wolf Lake Drive | Memphis | TN | 38133 |
| K152744 | GYRUS ACMI, INC |
136 TURNPIKE ROAD | SOUTHBOROUGH | MA | 01772 |
| K212650 | Gyrus ACMI, Inc. |
800 West Park Drive | Westborough | MA | 01581 |
| K121678 | GYRUS ACMI, INC. |
136 TURNPIKE RD. | SOUTHBOROUGH | MA | 01772 |
| K020594 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K034004 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K973286 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K992994 | GYRUS ENT L.L.C. |
2925 APPLING RD. | BARTLETT | TN | 38133 |
| K190715 | Interscope, Inc. |
100 Main Street, Suite 108 | Whitinsville | MA | 01588 |
| K150969 | KARL STORZ ENDOSCOPY AMERICA, INC. |
2151 E. GRAND AVE | EL SEGUNDO | CA | 90245 |
| K053262 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K003994 | KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE | CULVER CITY | CA | 90230-7600 |
| K200318 | Karl Storz Endoscopy-America, Inc. |
2151 E. Grand Avenue | El Segundo | CA | 90245 |
| K163247 | LAURIMED LLC |
500 ARGUELLO ST., SUITE 100 | REDWOOD CITY | CA | 94063 |
| K133133 | LAURIMED LLC |
8 CROW CANYON COURT, STE 205 | SAN RAMON | CA | 94583 |
| K161101 | LAURIMED LLC |
500 ARGUELLO ST., SUITE 100 | REDWOOD CITY | CA | 94063 |
| K964548 | LINVATEC CORP. |
11311 CONCEPT BLVD. | LARGO | FL | 33773-4908 |
| K981637 | LINVATEC CORP. |
11311 CONCEPT BLVD. | LARGO | FL | 33773-4908 |
| K961192 | LINVATEC CORP. |
11311 CONCEPT BLVD. | LARGO | FL | 33773-4908 |
| K974174 | MEDNET LOCATOR, INC. |
7000 SHADOW OAKS | MEMPHIS | TN | 38125 |
| K972057 | MEDTREK CORP. |
1204 MAIN ST., SUITE 224 | BRANFORD | CT | 06405 |
| K963246 | MEDTRONIC XOMED |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K002224 | MEDTRONIC XOMED |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K011321 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K041413 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K041523 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K073255 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K081277 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K150728 | MEDTRONIC XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216 |
| K970965 | MIDAS REX PNEUMATIC TOOLS, INC. |
3001 RACE ST. | FORT WORTH | TX | 76111-4117 |
| K962163 | MISTEN MEDICAL CORP. |
7220 STOUT RD. | GERMANTOWN | TN | 38138 |
| K021098 | MRI DEVICES DAUM GMBH |
P.O. BOX 4331 | CROFTON, | MD | 21114 |
| K021811 | MTP MEDICAL TECHNICAL PROMOTION GMBH |
600 CORPORATE POINTE | CULVER CITY | CA | 90230 |
| K080722 | NAKANISHI, INC. |
1425 K STREET, N.W. | WASHINGTON | DC | 20005 |
| K972865 | PROMEX, INC. |
1125 BROOKSIDE AVE. | INDIANAPOLIS | IN | 46202 |
| K012456 | SODEM SYSTEMS |
110 CH. DU PONT DU CENTENAIRE | GENEVA | CH-1228 | |
| K023070 | SODEM SYSTEMS |
110 CH. DU PONT DU CENTENAIRE | GENEVA | CH-1228 | |
| K081814 | STERILMED, INC. |
11400 73RD AVE. N, STE. 100 | MAPLE GROVE | MN | 55369 |
| K080052 | STRYKER CORP. |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K211490 | Stryker Corporation |
4100 East Milham Avenue | Kalamazoo | MI | 49001 |
| K152641 | STRYKER CORPORATION |
400 E. MILHAM AVENUE | KALAMAZOO | MI | 49001 |
| K171840 | Stryker Corporation |
4100 E. Milham Ave. | Kalamazoo | MI | 49001 |
| K141935 | STRYKER CORPORATION |
4100 E. MILHAM AVE | KALAMAZOO | MI | 49001 |
| K112593 | STRYKER CORPORATION |
4100 E. MILHAM AVE | KALAMAZOO | MI | 49001 |
| K990038 | Stryker Endoscopy |
2590 WALSH AVE. | SANTA CLARA | CA | 95051-4085 |
| K972584 | Stryker Endoscopy |
2590 WALSH AVE. | SANTA CLARA | CA | 95051-4085 |
| K011381 | STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K040300 | STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K073633 | STRYKER IRELAND LTD., INSTRUMENTS DIVISION |
CARRIGTWOHILL BUSINESS & | CARRIGTWOHILL, CO.CORK | ||
| K983050 | SURGICAL LASER TECHNOLOGIES, INC. |
147 KEYSTONE DR. | MONTGOMERYVILLE | PA | 18936 |
| K981041 | SURGICAL LASER TECHNOLOGIES, INC. |
147 KEYSTONE DR. | MONTGOMERYVILLE | PA | 18936 |
| K965080 | THE ANSPACH EFFORT, INC. |
4500 RIVERSIDE DR. | PALM BEACH GARDENS | FL | 33410 |
| K131053 | THE ANSPACH EFFORT, INC. |
3012 ST. CHARLES DRIVE | TAMPA | FL | 33618 |
| K180063 | The Anspach Effort, Inc. |
4500 Riverside Drive | Palm Beach Gardens | FL | 33410 |
| K213221 | W&H Dentalwerk Buermoss GmbH |
Ignaz-Glaser-Strasse 53 | Buermoos | 5111 | |
| K983224 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
| K002828 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
| K972453 | XOMED, INC. |
6743 SOUTHPOINT DR. NORTH | JACKSONVILLE | FL | 32216-0980 |
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