Rocklin, CA, US · 3 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | Class II | Cardiovascular | 3 | 2022-06-03 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-07-09 | Class II | Ongoing | Z-2325-2021 | EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not S… | — | EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance |
| 2021-07-09 | Class II | Ongoing | Z-2324-2021 | CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, N… | — | CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance |