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Sign in to claim this brandALLEN MEDICAL SYSTEMS, INC.
US
Last updated May 27, 2026
Information
- Country
- US
- Address
- —
- Website
- arthrex.com
- —
- —
- [email protected]
- Phone
- +1(800)934-4404
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 147805894
Catalogue (42)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Arthrex | AR-6529-16 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-12 | FDA UDI | Class I | Active |
| Arthrex | AR-1650-04 | FDA UDI | Class I | Active |
| Arthrex | AR-1627-05 | FDA UDI | Class I | Active |
| Arthrex | AR-1713-02 | FDA UDI | Class I | Active |
| Arthrex | AR-1627-10 | FDA UDI | Class I | Active |
| Arthrex | AR-1650-05 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-15 | FDA UDI | Class I | Active |
| Arthrex | AR-1627-11 | FDA UDI | Class I | Active |
| Arthrex | AR-1627-17 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-03 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-09 | FDA UDI | Class I | Active |
| Arthrex | AR-1650-08 | FDA UDI | Class I | Active |
| Arthrex | AR-1650-11 | FDA UDI | Class I | Active |
| Arthrex | AR-1713-01 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-05L | FDA UDI | Class I | Active |
| Arthrex | AR-1650-01 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-07 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-01 | FDA UDI | Class I | Active |
| Arthrex | AR-1713-03 | FDA UDI | Class I | Active |
| Arthrex | AR-1627-12EU | FDA UDI | Class I | Active |
| Arthrex | AR-1650-09 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-10 | FDA UDI | Class I | Active |
| Arthrex | AR-1627-11EU | FDA UDI | Class I | Active |
| Arthrex | AR-6529-20 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-18 | FDA UDI | Class I | Active |
| Arthrex | AR-1627-11UK | FDA UDI | Class I | Active |
| Arthrex | AR-1713-04 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-08 | FDA UDI | Class I | Active |
| Arthrex | AR-1627-12 | FDA UDI | Class I | Active |
| Arthrex | AR-1627-18 | FDA UDI | Class I | Active |
| Arthrex | AR-1650-07 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-19 | FDA UDI | Class I | Active |
| Arthrex | AR-6529-14L | FDA UDI | Class I | Active |
| Arthrex | AR-1650-10 | FDA UDI | Class I | Active |
| Arthrex | AR-1627-20 | FDA UDI | Class I | Active |
| Arthrex | AR-1627-15 | FDA UDI | Class I | Active |
| Dura-Board Armboard | K964273 | FDA 510(k) | Class I | Active |
| Allen, Ultra And Smart Sockets | K971988 | FDA 510(k) | Class I | Active |
| Carbon Lights Hand Surgery Table | K944779 | FDA 510(k) | Class I | Active |
| Allen Infusion Pump Model 3000 And Irrigation 2000 | K921168 | FDA 510(k) | Class I | Active |
| High Volume I.v. & Irrigation Tower | K960027 | FDA 510(k) | Class I | Active |
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 21, 2018 | Z-1262-2018 | — | terminated | The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient. |
| Oct 6, 2017 | Z-0642-2018 | — | terminated | The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. |
| Oct 6, 2017 | Z-0641-2018 | — | terminated | The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame. |