Ortho8, Inc.
Ortho8, Inc. holds FDA 510(k) medical device clearances, first cleared 2021, most recent 2022, with 2 FDA device recalls on record.
Top product codes for Ortho8, Inc.
FDA recalls by Ortho8, Inc.
- Z-2324-2021 — CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
- 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 Sterile
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ortho8, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.