Ortho8, Inc.
Ortho8, Inc. appears in FDA public data with 2 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2324-2021, Class II) was initiated on July 9, 2021. Its most recent 510(k) clearance was granted on June 3, 2022.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2324-2021 | Class II | CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx | July 9, 2021 |
| Z-2325-2021 | Class II | EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE | July 9, 2021 |