FDA 510(k) Applications for Medical Device:
Hearing Aid, Bone Conduction
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K121793 | AUDIFON-USA INC. |
403 CHAIRMAN CT., STE. 1 | DEBARY | FL | 32713 |
| K243041 | BHM-Tech Produktionsgesellschaft mbH |
Grafenschachen 242 | Grafenschachen | 7423 | |
| K250215 | Cochlear |
10350 Park Meadows Drive | Lone Tree | CO | 80214 |
| K110996 | COCHLEAR AMERICAS |
13059 E. PEAKVIEW AVE | CENTENNIAL | CO | 80111 |
| K161123 | Cochlear Americas |
13059 E. Peakview Avenue | Centennial | CO | 80111 |
| K142907 | COCHLEAR AMERICAS |
13059 EAST PEAKVIEW AVENUE | CENTENNIAL | CO | 80111 |
| K153245 | COCHLEAR AMERICAS |
13059 E. PEAKVIEW AVE | CENTENNIAL | CO | 80111 |
| K081606 | COCHLEAR AMERICAS |
400 INVERNESS PARKWAY, | ENGLEWOOD | CO | 80112 |
| K100360 | COCHLEAR AMERICAS |
13059 E PEAKVIEW AVE | CENTENNIAL | CO | 80111 |
| K132278 | COCHLEAR AMERICAS |
13059 EAST PEAKVIEW AVENUE | CENTENNIAL | CO | 80111 |
| K202048 | Cochlear Americas |
10350 Park Meadows Drive | Lone Tree | CO | 80124 |
| K212136 | Cochlear Americas |
10350 Park Meadows Dr | Lone Tree | CO | 80124 |
| K131240 | COCHLEAR AMERICAS |
13059 EAST PEAKVIEW AVENUE | CENTENNIAL | CO | 80111 |
| K171088 | Cochlear Americas |
13059 E. Peakview Avenue | Centennial | CO | 80111 |
| K150751 | COCHLEAR AMERICAS |
13059 E PEAKVIEW AVENUE | CENTENNIAL | CO | 80111 |
| K090720 | COCHLEAR BONE ANCHORED SYSTEMS AB |
13059 E. PEAKVIEW AVE. | CENTENNIAL | CO | 80111 |
| K062404 | EAR TECHNOLOGY CORP. |
106 E WATAUGA AVE. | JOHNSON CITY | TN | 37601 |
| K042017 | ENTIFIC MEDICAL SYSTEMS, INC. |
6470 RIVERVIEW TERRACE | MINNEAPOLIS | MN | 55432 |
| K011438 | ENTIFIC MEDICAL SYSTEMS, INC. |
6470 RIVERVIEW TERRACE | MINNEAPOLIS | MN | 55432 |
| K992872 | ENTIFIC MEDICAL SYSTEMS, INC. |
8944 TAMAROA TERRACE | SKOKIE | IL | 60076 |
| K021837 | ENTIFIC MEDICAL SYSTEMS, INC. |
6470 RIVERVIEW TERRACE | MINNEAPOLIS | MN | 55432 |
| K002913 | ENTIFIC MEDICAL SYSTEMS, INC. |
6470 RIVERVIEW TERRACE | MINNEAPOLIS | MN | 55432 |
| K172460 | MED-EL Elektromedizinische Geraete GmbH |
Fuerstenweg 77a | Innsbruck | 6020 | |
| K955713 | NOBELPHARMA USA, INC. |
777 OAKMONT LN. | WESTMONT | IL | 60559 |
| K082108 | OTICON MEDICAL AB |
EKONOMIV 2 | GOTHENBURG, ASKIM | SE-436 33 | |
| K161671 | OTICON MEDICAL AB |
DATAVAGEN 37B | ASKIM | SE-436 32 | |
| K190540 | Oticon Medical AB |
Datavagen 37 B | Askim | SE-436 32 | |
| K211640 | Oticon Medical AB |
Datavagen 37B | Askim | SE-436 32 | |
| K213733 | Oticon Medical AB |
Datavagen 37B | Askim | SE-436 32 | |
| K132775 | OTICON MEDICAL AB |
EKONOMIVAGEN 2 | ASKIM | SE-436 33 | |
| K090996 | OTICON MEDICAL AB |
EKONOMIV 2 | GOTHENBURG, ASKIM | SE-436 33 | |
| K103594 | OTICON MEDICAL AB |
EKONOMIV 2 | GOTHENBURG, ASKIM | SE-436 33 | |
| K100649 | SONITUS MEDICAL INC |
25 HARTFORD AVE | SAN CARLOS | CA | 94070 |
| K110831 | SONITUS MEDICAL INC |
25 HARTFORD AVENUE | SAN CARLOS | CA | 94070 |
| K153391 | SOPHONO INC. |
5744 CENTRAL AVE #100 | BOULDER | CO | 80301 |
| K132189 | SOPHONO, INC |
5744 CENTRAL AVENUE #100 | BOULDER | CO | 80301 |
| K100193 | SOPHONO, INC |
555 ZANG STREET | LAKEWOOD | CO | 80228 |
| K123962 | SOPHONO, INC |
5744 CENTRAL AVENUE #100 | BOULDER | CO | 80301 |
| K102199 | SOPHONO, INC |
555 ZANG STREET | LAKEWOOD | CO | 80228 |
| K050653 | UNITED HEARING SYSTEMS, INC. |
137 NORWICH RD. | CENTRAL VILLAGE | CT | 06332 |
| K953872 | WORDCOMP INTERNATIONAL COMMUNICATION GROUP (WICG) |
1000 BUNNETT AVE. | CONCORD | CA | 94520 |
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