This page includes the latest FDA filings for Hyperfine Operations Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
| Hyperfine Operations, Inc. | Swoop Transmit and Receive Radio Frequency Head Coil 900-11015-01 | 2025-12-12 |
| Hyperfine Operations, Inc. | Swoop Portable MR Imaging Scanner 900-11050-02 | 2025-12-12 |
| Hyperfine Operations, Inc. | Hyperfine Foam Head Pad | 2025-03-13 |