OrganOx Limited
Oxford Oxfordshire, GB
ORGANOX LIMITED appears in FDA device records in Oxford Oxfordshire, GB. FDA records list no 510(k) clearances, 40 PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011560054 | 3011560054 | ORGANOX LIMITED | 3500 John Smith Drive, Oxford Oxfordshire OX4 2WB GB | 2026 | |
| 3022300078 | 3022300078 | OrganOx Inc. | 7 Giralda Farms Suite 130, Madison, NJ 07940 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0501-2025 | OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. | Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain