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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 29 of 91

Device	Model / Reference	Registries	Class	Status
Lumex	FR566DG9214PA	FDA UDI	Class I	Active
Lumex	FR587WDH6727	FDA UDI	Class I	Active
Everest & Jennings	907632B1A	FDA UDI	Class I	Active
Everest & Jennings	EJ783-1	FDA UDI	Class I	Active
Intensa	IN566DGH6725PA	FDA UDI	Class I	Active
Intensa	IN601UHBL	FDA UDI	Class I	Active
Intensa	460-FS-PS-VI	FDA UDI	Class I	Active
Everest & Jennings	8265188	FDA UDI	Class I	Active
Intensa	620-DA-T9	FDA UDI	Class I	Active
Everest & Jennings	3K010150	FDA UDI	Class I	Active
Grafco	1306	FDA UDI	Class I	Active
Intensa	7408-B-SH	FDA UDI	Class I	Active
Intensa	IN577RGH1318PA	FDA UDI	Class I	Active
Hausted	6200DA-AL	FDA UDI	Class I	Active
Labtron	500	FDA UDI	Class I	Active
Intensa	460-NO	FDA UDI	Class I	Active
Intensa	IN566GBUPA	FDA UDI	Class I	Active
Hausted	4600-AA-DW-MO	FDA UDI	Class I	Active
Intensa	420-DW-AL	FDA UDI	Class I	Active
Intensa	IN566GPLPA	FDA UDI	Class I	Active
Intensa	IN587WH1304PA	FDA UDI	Class I	Active
Grafco	2688	FDA UDI	Class I	Active
Hausted	4600-AA-PS-AL	FDA UDI	Class I	Active
Lumex	FR566G9214PA	FDA UDI	Class I	Active
Everest & Jennings	907632C3A	FDA UDI	Class I	Active
Lumex	FR566DG1319PA	FDA UDI	Class I	Active
Intensa	7408-B-PU	FDA UDI	Class I	Active
Hausted	4600-AA-PS-WH	FDA UDI	Class I	Active
Gendron	7150P1199	FDA UDI	Class I	Active
Everest & Jennings	5PX10830	FDA UDI	Class I	Active
Lumex	FR565WG8624	FDA UDI	Class I	Active
Everest & Jennings	EJ78-FRPINK	FDA UDI	Class I	Active
Lumex	FR566DGH8504	FDA UDI	Class I	Unknown
Intensa	460-FS-PS-DB	FDA UDI	Class I	Active
Lumex	FR565WG8533	FDA UDI	Class I	Active
Hausted	4200-EO-WW	FDA UDI	Class I	Active
Lumex	FR587WH1304	FDA UDI	Class I	Active
Lumex	FR587WD401PA	FDA UDI	Class I	Active
Lumex	FR597G409	FDA UDI	Class I	Active
Intensa	620-TL	FDA UDI	Class I	Active
Intensa	IN587WD6705	FDA UDI	Class I	Active
Lumex	FR601UH8516	FDA UDI	Class I	Active
Lumex	FR597G6705	FDA UDI	Class I	Active
Lumex	FR565WG427	FDA UDI	Class I	Active
Intensa	IN587WDAQ	FDA UDI	Class I	Active
Lumex	FR566GH9201	FDA UDI	Class I	Active
Intensa	748CB-TL	FDA UDI	Class I	Active
Intensa	IN566DGH1325	FDA UDI	Class I	Active
Intensa	460-FS-DW-T8	FDA UDI	Class I	Active
Intensa	460-FS-AA-PS-OG	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.