N/A
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| N/A | 5 | N | 2026-01-01 | N/A N/A N/A NA US N/A | ||
| N/A | 5 | N | 2026-01-01 | N/A N/A N/A NA US N/A | ||
| N/A | 5 | N | 2026-01-01 | N/A N/A N/A NA US N/A | ||
| N/A | 5 | N | 2026-01-01 | N/A N/A N/A NA US N/A | ||
| N/A | 5 | N | 2026-01-01 | N/A N/A N/A NA US N/A | ||
| N/A | 5 | N | 2026-01-01 | N/A N/A N/A NA US N/A | ||
| 3004105180 | 3004105180 | N/A | 1 | N | 2026-01-01 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
| 0 | 0 | N/A | 5 | N | 2020-04-25 | N/A N/A N/A NA US N/A |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 82814 | 1328072383 | K902591 | CYTETTE(TM) CYTOLOGY BRUSH | HHT | 1990-09-10 |
| 82814 | 2004956266 | K902589 | CYTOSET(TM) | HHT | 1990-09-10 |
| 352973 | 1608902903 | K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) | LXB | 2026-08-19 |
| 352926 | 2022263016 | K060019 | ARTON ONE-STEP HCG URINARY PREGNANCY TEST (STRIP), (CASSETTE), (MIDSTREAM) | LCX | 2006-02-17 |
| 251286 | 1001068033 | ||||
| 251078 | 1019104876 | ||||
| 242107 | 1020294449 | ||||
| 244833 | 1025077421 | ||||
| 254747 | 1036244431 | ||||
| 249223 | 1091330977 | ||||
| 241341 | 1104337456 | ||||
| 242135 | 1122962084 | ||||
| 254747 | 1129200025 | ||||
| 244806 | 1174940849 | ||||
| 244833 | 1334955141 | ||||
| 242901 | 1452598388 | ||||
| 251286 | 1513875047 | ||||
| 242107 | 1541013844 | ||||
| 251059 | 1563122222 | ||||
| 242901 | 1588750799 | ||||
| 245775 | 1610432504 | ||||
| 242135 | 1615992760 | ||||
| 244832 | 1632312841 | ||||
| 251421 | 1656492504 | ||||
| 254449 | 1659148641 | ||||
| 249223 | 1741166057 | ||||
| 247861 | 1743321763 | ||||
| 251059 | 1746701297 | ||||
| 251078 | 1752688293 | ||||
| 249223 | 1828012377 | ||||
| 251421 | 1882221047 | ||||
| 245775 | 1901564909 | ||||
| 242107 | 1917277740 | ||||
| 244603 | 1952765655 | ||||
| 244784 | 1984222903 | ||||
| 244806 | 2028090901 | ||||
| 251286 | 2040908854 | ||||
| 352926 | 1020447573 | ||||
| 352894 | 1181789257 | ||||
| 352507 | 1769657713 | ||||
| 82814 | 1774787438 | ||||
| 82814 | 1789866514 | ||||
| 352507 | 1813578402 | ||||
| 351534 | 1945311536 | ||||
| 352812 | 2064465737 |