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Sign in to claim this brandGF Health Products, Inc
United States·US-MF-000002167
Last updated September 17, 2026
Information
- Country
- United States
- Address
- One Graham Field Way, Atlanta, United States
- Website
- www.grahamfield.com
- —
- —
- [email protected]
- Phone
- +17703684700
- PRRC Contact
- Amy Piccini
- EUDAMED SRN
- US-MF-000002167
- FDA FEI Number
- 2427360
- DUNS Number
- —
Catalogue (4538)
Page 1 of 91| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Intensa | IN566GH8567PA | FDA UDI | Class I | Active |
| Intensa | IN597GAL | FDA UDI | Class I | Active |
| Intensa | IN566G6725PA | FDA UDI | Class I | Active |
| Intensa | 420-EO-T8 | FDA UDI | Class I | Active |
| Intensa | IN597G9205 | FDA UDI | Class I | Active |
| Intensa | IN587WH9205 | FDA UDI | Class I | Active |
| Intensa | 460-PS-T7 | FDA UDI | Class I | Active |
| Intensa | IN597PMO | FDA UDI | Class I | Active |
| Lumex | SAL1230-KB | FDA UDI | Class I | Active |
| Hausted | 4600-OG | FDA UDI | Class I | Active |
| Intensa | IN566G1323PA | FDA UDI | Class I | Active |
| Graham Field | 201BK | FDA UDI | Class II | Active |
| Gendron | G1600 | FDA UDI | Class II | Active |
| Grafco | 3786-12#2 | FDA UDI | Class I | Active |
| Lumex | FR566G6717PA | FDA UDI | Class I | Active |
| Lumex | LF1030S | FDA UDI | Class I | Active |
| Intensa | 620-DA-DB | FDA UDI | Class I | Active |
| Intensa | IN566GH9201 | FDA UDI | Class I | Active |
| Lumex | FR588W863 | FDA UDI | Class I | Active |
| Lumex | FR587WH9214 | FDA UDI | Class I | Active |
| Intensa | IN601PHPL | FDA UDI | Class I | Active |
| Basic American Medical Products | APS78174 | FDA UDI | Class II | Active |
| Intensa | 460-DW-ST | FDA UDI | Class I | Active |
| Transfer Master | B306-FSL | FDA UDI | Class II | Active |
| Intensa | IN577RGHNAPA | FDA UDI | Class I | Active |
| Hausted | 4600-AA-PS-DB | FDA UDI | Class I | Active |
| Lumiscope | 100-040P | FDA UDI | Class II | Active |
| Intensa | IN587WSH | FDA UDI | Class I | Active |
| Intensa | IN566DG401PA | FDA UDI | Class I | Active |
| Lumex | DSC250 | FDA UDI | Class I | Active |
| Hausted | 4200-BU | FDA UDI | Class I | Active |
| Lumex | FR566GH1305 | FDA UDI | Class I | Active |
| Lumex | FR587WDH409PA | FDA UDI | Class I | Active |
| Lumex | FR601UH8615 | FDA UDI | Class I | Active |
| Lumex | FR587WDH8516PA | FDA UDI | Class I | Active |
| Intensa | 460-AA-AR | FDA UDI | Class I | Active |
| Lumex | 2100A | FDA UDI | Class I | Active |
| Intensa | IN587WDH1304PA | FDA UDI | Class I | Active |
| Intensa | IN566DGNAPA | FDA UDI | Class I | Active |
| Grafco | 1305 | FDA UDI | Class I | Active |
| Lumiscope | 1143 | FDA UDI | Class II | Active |
| Hausted | 4600-DW-BL | FDA UDI | Class I | Active |
| Lumex | FR587WH6705PA | FDA UDI | Class I | Active |
| Lumex | FR566DGH6717 | FDA UDI | Class I | Active |
| Lumex | FR597G427 | FDA UDI | Class I | Active |
| Intensa | 620-AR | FDA UDI | Class I | Active |
| Intensa | 744B-T2 | FDA UDI | Class I | Active |
| Grafco | 9678 | FDA UDI | Class I | Active |
| Hausted | 4600-FL-BT | FDA UDI | Class I | Active |
| Lumex | 2101A | FDA UDI | 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 |
|---|---|---|---|---|
| Mar 24, 2021 | Z-1353-2021 | — | terminated | The front casters on the 6810A Lumex Drop Arm Versamode are incorrect. |
| Sep 30, 2016 | Z-0732-2017 | — | terminated | GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America "DUOMAT 3" Head/Foot motor used in the manufacture of our Lumex Patriot Full Electric Bed Model US0458/US0468 and Patriot LX Full Electric Bed Model US6000. The failure mode is directly related to contaminated material in the plastic housing used to produce the DUOMAT 3 motor. Contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended design. If the head section were to fall it is unlikely but possible an injury could occur. No injuries have been reported. |
| Sep 14, 2009 | Z-0139-2010 | — | terminated | Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications. |