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GF 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
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +17703684700
PRRC Contact: Amy Piccini
EUDAMED SRN: US-MF-000002167
FDA FEI Number: 2427360
DUNS Number: —

Catalogue (4538)

Page 86 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN577RGBUPA	FDA UDI	Class I	Active
Intensa	IN566DGHVI	FDA UDI	Class I	Active
Intensa	IN566DGHTE	FDA UDI	Class I	Active
Intensa	IN566DGH427	FDA UDI	Class I	Active
Labtron	1227-4	FDA UDI	Class II	Active
Everest & Jennings	90763206A	FDA UDI	Class I	Active
Intensa	IN566DG8516PA	FDA UDI	Class I	Active
Everest & Jennings	8930228	FDA UDI	Class I	Active
Intensa	IN566GH9210PA	FDA UDI	Class I	Active
Intensa	IN587WBU	FDA UDI	Class I	Active
Intensa	460-AA-DW-T1	FDA UDI	Class I	Active
Intensa	IN577RGHWW	FDA UDI	Class I	Active
Intensa	460-FS-DW-T9	FDA UDI	Class I	Active
Intensa	744-AQ	FDA UDI	Class I	Active
Intensa	IN566DGHWHPA	FDA UDI	Class I	Active
Intensa	IN577RGHMOPA	FDA UDI	Class I	Active
Grafco	GRA2810	FDA UDI	Class I	Active
Intensa	IN597P8584	FDA UDI	Class I	Active
Intensa	IN566GH9210	FDA UDI	Class I	Active
Intensa	748B-WH	FDA UDI	Class I	Active
Intensa	IN587WDMO	FDA UDI	Class I	Active
Intensa	460-FS-MO	FDA UDI	Class I	Active
Everest & Jennings	EJ796-1	FDA UDI	Class I	Active
Intensa	IN566DGHNA	FDA UDI	Class I	Active
Intensa	620-NO	FDA UDI	Class I	Active
Gendron	PL1000	FDA UDI	Class II	Active
Intensa	IN566DG9210	FDA UDI	Class I	Active
Gendron	GS4054D	FDA UDI	Class II	Active
Intensa	IN601PHMO	FDA UDI	Class I	Active
Intensa	IN566DGH6727	FDA UDI	Class I	Active
Intensa	IN566G8602	FDA UDI	Class I	Active
Intensa	IN566GH9214PA	FDA UDI	Class I	Active
Grafco	1196F	FDA UDI	Class I	Active
Intensa	IN587W427	FDA UDI	Class I	Active
Intensa	744B-GR	FDA UDI	Class I	Active
Intensa	460-FL-T2	FDA UDI	Class I	Active
Lumiscope	100-019	FDA UDI	Class II	Active
Basic American Medical Products	APS78674	FDA UDI	Class II	Active
Grafco	2672	FDA UDI	Class I	Active
Intensa	IN597G9201	FDA UDI	Class I	Active
Grafco	2634	FDA UDI	Class I	Active
Everest & Jennings	90763450	FDA UDI	Class I	Unknown
Intensa	IN587WD6714	FDA UDI	Class I	Active
Intensa	IN577RGH8602PA	FDA UDI	Class I	Active
Intensa	IN587WD8604	FDA UDI	Class I	Active
Intensa	748-GR	FDA UDI	Class I	Active
Intensa	460-FS-AA-AL	FDA UDI	Class I	Active
Intensa	460-AA-NA	FDA UDI	Class I	Active
Intensa	IN566GH1311	FDA UDI	Class I	Active
Intensa	IN587WBLPA	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.