This page includes the latest FDA filings for Ergodyne. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Ergodyne holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
Device Company | Device | Date |
|---|---|---|
| Ergodyne | Skullerz 60315 | 2025-02-05 |
| Ergodyne | Skullerz 60313 | 2025-02-05 |
| Ergodyne | Skullerz 60311 | 2023-09-06 |
| Ergodyne | Skullerz 60310 | 2023-09-06 |
| Ergodyne | Skullerz 60309 | 2023-09-06 |
| Ergodyne | Skullerz 60308 | 2023-09-06 |
| Ergodyne | Skullerz 60307 | 2023-09-06 |
| Ergodyne | Skullerz 60306 | 2023-09-06 |
| Ergodyne | Skullerz 60305 | 2023-09-06 |
| Ergodyne | Skullerz 60304 | 2023-09-06 |
| Ergodyne | Skullerz 60303 | 2023-09-06 |
| Ergodyne | Skullerz 60302 | 2023-09-06 |
| Ergodyne | Skullerz 60301 | 2023-09-06 |
| Ergodyne | Skullerz 60300 | 2023-09-06 |
| Ergodyne | Skullerz 59285 | 2023-09-06 |
| Ergodyne | Skullerz 59283 | 2023-09-06 |
| Ergodyne | Skullerz 59280 | 2023-09-06 |
| Ergodyne | Skullerz 59235 | 2023-09-06 |
| Ergodyne | Skullerz 59233 | 2023-09-06 |
| Ergodyne | Skullerz 59230 | 2023-09-06 |
| Ergodyne | Skullerz 59205 | 2023-09-06 |
| Ergodyne | Skullerz 59203 | 2023-09-06 |
| Ergodyne | Skullerz 59200 | 2023-09-06 |
| Ergodyne | Skullerz 59185 | 2023-09-06 |
| Ergodyne | Skullerz 59183 | 2023-09-06 |
| Ergodyne | Skullerz 59180 | 2023-09-06 |
| Ergodyne | Skullerz 59135 | 2023-09-06 |
| Ergodyne | Skullerz 59133 | 2023-09-06 |
| Ergodyne | Skullerz 59130 | 2023-09-06 |
| Ergodyne | Skullerz 59105 | 2023-09-06 |
| Ergodyne | Skullerz 59100 | 2023-09-06 |
| Ergodyne | Skullerz 59080 | 2023-09-06 |
| Ergodyne | Skullerz 59035 | 2023-09-06 |
| Ergodyne | Skullerz 59033 | 2023-09-06 |
| Ergodyne | Skullerz 59030 | 2023-09-06 |
| Ergodyne | Skullerz 59005 | 2023-09-06 |
| Ergodyne | Skullerz 59003 | 2023-09-06 |
| Ergodyne | Skullerz 59000 | 2023-09-06 |
| Ergodyne | Skullerz 57433 | 2023-09-06 |
| Ergodyne | Skullerz 50550 | 2023-09-06 |
| Ergodyne | Skullerz 50530 | 2023-09-06 |
| Ergodyne | Skullerz 50520 | 2023-09-06 |
| Ergodyne | Skullerz 50500 | 2023-09-06 |
| Ergodyne | Skullerz 50442 | 2023-09-06 |
| Ergodyne | Skullerz 50430 | 2023-09-06 |
| Ergodyne | Skullerz 50400 | 2023-09-06 |
| Ergodyne | Skullerz 50350 | 2023-09-06 |
| Ergodyne | Skullerz 50330 | 2023-09-06 |
| Ergodyne | Skullerz 50320 | 2023-09-06 |
| Ergodyne | Skullerz 50300 | 2023-09-06 |
| Ergodyne | Skullerz 50242 | 2023-09-06 |
| Ergodyne | Skullerz 50230 | 2023-09-06 |
| Ergodyne | Skullerz 57430 | 2023-09-05 |
| Ergodyne | Skullerz 57403 | 2023-09-05 |
| Ergodyne | Skullerz 57333 | 2023-09-05 |
| Ergodyne | Skullerz 57331 | 2023-09-05 |
| Ergodyne | Skullerz 57330 | 2023-09-05 |
| Ergodyne | Skullerz 57320 | 2023-09-05 |
| Ergodyne | Skullerz 57150 | 2023-09-05 |
| Ergodyne | Skullerz 57133 | 2023-09-05 |
| Ergodyne | Skullerz 57103 | 2023-09-01 |
| Ergodyne | Skullerz 57100 | 2023-09-01 |
| Ergodyne | Skullerz 57083 | 2023-09-01 |
| Ergodyne | Skullerz 57080 | 2023-09-01 |
| Ergodyne | Skullerz 57042 | 2023-09-01 |
| Ergodyne | Skullerz 57033 | 2023-09-01 |
| Ergodyne | Skullerz 57031 | 2023-09-01 |
| Ergodyne | Skullerz 57030 | 2023-09-01 |
| Ergodyne | Skullerz 57003 | 2023-09-01 |
| Ergodyne | Skullerz 57000 | 2023-08-31 |
| Ergodyne | Skullerz 56180 | 2023-08-31 |
| Ergodyne | Skullerz 56150 | 2023-08-31 |
| Ergodyne | Skullerz 56133 | 2023-08-31 |
| Ergodyne | Skullerz 56131 | 2023-08-31 |
| Ergodyne | Skullerz 56121 | 2023-08-31 |
| Ergodyne | Skullerz 56103 | 2023-08-31 |
| Ergodyne | Skullerz 56100 | 2023-08-31 |
| Ergodyne | Skullerz 56092 | 2023-08-31 |
| Ergodyne | Skullerz 56080 | 2023-08-31 |
| Ergodyne | Skullerz 56050 | 2023-08-31 |
| Ergodyne | Skullerz 56035 | 2023-08-31 |
| Ergodyne | Skullerz 56021 | 2023-08-31 |
| Ergodyne | Skullerz 56005 | 2023-08-31 |
| Ergodyne | Skullerz 56005 | 2023-08-30 |
| Ergodyne | Skullerz 55105 | 2023-08-30 |
| Ergodyne | Skullerz 55104 | 2023-08-30 |
| Ergodyne | Skullerz 55014 | 2023-08-24 |
| Ergodyne | Skullerz 55013 | 2023-08-24 |
| Ergodyne | Skullerz 55012 | 2023-08-24 |
| Ergodyne | Skullerz 55011 | 2023-08-24 |
| Ergodyne | Skullerz 55010 | 2023-08-24 |
| Ergodyne | Skullerz 55009 | 2023-08-24 |
| Ergodyne | Skullerz 55008 | 2023-08-24 |
| Ergodyne | Skullerz 55007 | 2023-08-24 |
| Ergodyne | Skullerz 55006 | 2023-08-24 |
| Ergodyne | Skullerz 55005 | 2023-08-24 |
| Ergodyne | Skullerz 55004 | 2023-08-24 |
| Ergodyne | Skullerz 55003 | 2023-08-24 |
| Ergodyne | Skullerz 55002 | 2023-08-24 |
| Ergodyne | Skullerz 55001 | 2023-08-24 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2019061351330 | Kobe,Japan -> Los Angeles, California | MULTIHOOK | 7 CTN |
| 2019022026104 | Kobe,Japan -> Long Beach, California | MULTI HOOK | 9 CTN |
| 2019021138863 | Kobe,Japan -> Long Beach, California | MULTI HOOK | 9 CTN |
| 2019011142368 | Kobe,Japan -> Long Beach, California | MULTI HOOK | 15 CTN |
| 2018111741978 | Kobe,Japan -> Long Beach, California | MULTI HOOK | 21 CTN |