Is this your brand? Sign in to claim ownership.

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 8 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN587WDHBU	FDA UDI	Class I	Active
Labtron	722Y	FDA UDI	Class I	Active
Intensa	748B-AQ	FDA UDI	Class I	Active
Intensa	420-DW-AR	FDA UDI	Class I	Active
Intensa	7408-CB-BL	FDA UDI	Class I	Active
Intensa	IN597PPM	FDA UDI	Class I	Active
Lumex	FR587WDH9208PA	FDA UDI	Class I	Active
Everest & Jennings	907630A1A	FDA UDI	Class I	Active
Intensa	460-FS-T2	FDA UDI	Class I	Active
Intensa	IN566G432PA	FDA UDI	Class I	Active
Intensa	IN587WH427PA	FDA UDI	Class I	Active
Intensa	IN601PGR	FDA UDI	Class I	Active
Lumex	FR566DG9208PA	FDA UDI	Class I	Active
Intensa	IN566DG8516	FDA UDI	Class I	Active
Hausted	4200-DW-WH	FDA UDI	Class I	Active
Grafco	2750	FDA UDI	Class I	Active
Intensa	IN566DGPM	FDA UDI	Class I	Active
Intensa	IN566DG6724	FDA UDI	Class I	Active
Intensa	IN587WDHPMPA	FDA UDI	Class I	Active
Lumex	FR587WH409PA	FDA UDI	Class I	Active
Intensa	IN566GH9214	FDA UDI	Class I	Active
Intensa	IN577RGALPA	FDA UDI	Class I	Active
Lumex	LF2020	FDA UDI	Class I	Active
Intensa	IN566G1304PA	FDA UDI	Class I	Active
Everest & Jennings	3H020130	FDA UDI	Class I	Active
Intensa	744B-COM	FDA UDI	Class I	Active
M368in566g409pa1	IN566G409PA	FDA UDI	Class I	Active
Lumex	US0208	FDA UDI	Class II	Active
Intensa	IN587W1305PA	FDA UDI	Class I	Active
Intensa	IN566GDB	FDA UDI	Class I	Active
Lumex	FR601UH8602	FDA UDI	Class I	Active
Grafco	1372-4	FDA UDI	Class I	Active
Intensa	IN566DGH1318PA	FDA UDI	Class I	Active
Hausted	4600-FS-AA-PS-VI	FDA UDI	Class I	Active
Lumex	7921A-4	FDA UDI	Class I	Active
Intensa	IN566G8615PA	FDA UDI	Class I	Active
Lumex	FR587WDH427	FDA UDI	Class I	Active
Everest & Jennings	EJ78-FRBLACK	FDA UDI	Class I	Active
Lumex	FR601UH1311	FDA UDI	Class I	Active
Hausted	4600-AR	FDA UDI	Class I	Active
Intensa	744B-PU	FDA UDI	Class I	Active
Intensa	IN566DGH9214PA	FDA UDI	Class I	Active
Labtron	602MAG	FDA UDI	Class I	Active
Intensa	IN566GHDOPA	FDA UDI	Class I	Active
Intensa	IN587WDGR	FDA UDI	Class I	Active
Intensa	460-AA-MO	FDA UDI	Class I	Active
Intensa	IN577RGHST	FDA UDI	Class I	Active
Hausted	4600-AA-DW-GR	FDA UDI	Class I	Active
Everest & Jennings	90763023A	FDA UDI	Class I	Active
Hausted	4600-AA-GR	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.