Ortho8, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2324-2021Class IICIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx July 9, 2021
Z-2325-2021Class IIEVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVEJuly 9, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K220761CIRCUL8 Connect DVT Prevention DeviceJune 3, 2022
K212731Circul8 ProNovember 15, 2021
K211235CIRCUL8 Luxe DVT Prevention DeviceSeptember 8, 2021