This page includes the latest FDA filings for Atom Medical Usa L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3011061384 |
| FEI Number | 3011061384 |
| Name | ATOM MEDICAL USA, LLC |
| Owner & Operator | Atom Medical USA, LLC |
| Contact Address | 150 Lake Drive Suite 101 Wexford PA 15090 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 150 Lake Drive Suite 101 Wexford, PA 15090 US |
Device Company | Device | Date |
|---|---|---|
| Atom Medical Usa, LLC | ATOM Medical USA, Disposable Probe | 2022-02-16 |
| NCAGE Code | 7FEY3 | ATOM MEDICAL USA, LLC!DBA ATOM MEDICAL USA |
| CAGE Code | 7FEY3 | ATOM MEDICAL USA, LLC ATOM MEDICAL USA |
| S.A.M. Registration | 7FEY3 [70066016] | ATOM MEDICAL USA, LLC ATOM MEDICAL USA |
| DUNS | 070066016 | Atom Medical USA, LLC |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 202009216271 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENT HS CODE: 9018.90, 9019.20, 9027.50 | 126 CTN |
| 2020081514597 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENT HS CODE:9018.90,8423.10,3926.90, | 189 CTN |
| 2020081516314 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | LITHIUM ION BATTERIES CONTAINED IN EQUIPMENT HS CODE 850760 | 3 CAS |
| 2020081015222 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENT HS CODE:9018.90,8423.10,9027.50 | 101 CTN |
| 2020081015222 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENT HS CODE:9018.90,8423.10,9027.50 | 101 CTN |
| 202007227244 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENT HS CODE:9018.90,8423.10,8507.60, 9402.90,8529.90 | 263 CTN |
| 202007227244 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENT HS CODE:9018.90,8423.10,8507.60, 9402.90,8529.90 | 263 CTN |
| 202006298253 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENT HS CODE:8423.10,9018.90 | 198 CTN |
| 2020050411357 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | MEDICAL EQUIPMENT HS CODE:9018.90,9027.50,9019.20, | 175 CTN |
| 2020050413018 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | LITHIUM ION BATTERIES CONTAINED IN EQUIPMENT HS CODE 850760 | 8 CAS |