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 74 of 91

Device	Model / Reference	Registries	Class	Status
Intensa	IN566G8584	FDA UDI	Class I	Active
Intensa	IN577RG6727	FDA UDI	Class I	Active
Grafco	1340-2	FDA UDI	Class I	Active
Lumiscope	L2013	FDA UDI	Class II	Active
Intensa	620-WH	FDA UDI	Class I	Active
Lumex	FR587W1318PA	FDA UDI	Class I	Active
Lumex	DSLSA9	FDA UDI	Class I	Active
Intensa	IN587W1319PA	FDA UDI	Class I	Active
Lumex	8220206	FDA UDI	Class I	Active
Intensa	IN587WHOG	FDA UDI	Class I	Active
Lumex	FR566GH6705	FDA UDI	Class I	Active
Intensa	IN566DGH9201	FDA UDI	Class I	Active
Everest & Jennings	3F020330	FDA UDI	Class I	Active
Intensa	IN577RGH401	FDA UDI	Class I	Active
Intensa	IN577RG9214	FDA UDI	Class I	Active
Intensa	748CB-COM	FDA UDI	Class I	Active
Lumex	FR577RGH9207	FDA UDI	Class I	Active
Intensa	IN566G1315PA	FDA UDI	Class I	Active
Intensa	IN587WD401	FDA UDI	Class I	Active
Basic American Medical Products	APS98674	FDA UDI	Class II	Active
Intensa	IN597GPU	FDA UDI	Class I	Active
Intensa	IN566GH454PA	FDA UDI	Class I	Active
Hausted	4600-DW-PU	FDA UDI	Class I	Active
Basic American Medical Products	Z7AF35	FDA UDI	Class II	Active
Lumex	FR587WH9207PA	FDA UDI	Class I	Active
Lumex	FR566DGH1311	FDA UDI	Class I	Active
Intensa	IN577RGBL	FDA UDI	Class I	Active
Lumex	FR587WDH6717	FDA UDI	Class I	Active
Grafco	1336	FDA UDI	Class I	Active
Lumex	FR565WG1304	FDA UDI	Class I	Active
Intensa	IN587WDHTEPA	FDA UDI	Class I	Active
Hausted	4600-DW-VI	FDA UDI	Class I	Active
Lumex	FR566DGH1304	FDA UDI	Class I	Active
Lumex	2215B-2	FDA UDI	Class I	Active
John Bunn	JB0112-067	FDA UDI	Class II	Active
Lumex	FR565WG6705	FDA UDI	Class I	Active
Intensa	IN601UNO	FDA UDI	Class I	Active
Intensa	460-PS-T9	FDA UDI	Class I	Active
Intensa	744CB-T10	FDA UDI	Class I	Active
Lumex	LF1600	FDA UDI	Class I	Active
Intensa	IN587W427PA	FDA UDI	Class I	Active
Lumex	FR577RGH8602	FDA UDI	Class I	Active
Intensa	IN587W454PA	FDA UDI	Class I	Active
Grafco	2768	FDA UDI	Class I	Active
Lumex	FR597P1315	FDA UDI	Class I	Active
Intensa	IN587WDHBTPA	FDA UDI	Class I	Active
Lumiscope	2000-T	FDA UDI	Class II	Active
Intensa	IN601UAR	FDA UDI	Class I	Active
Intensa	IN587WHBUPA	FDA UDI	Class I	Active
Intensa	IN566G1304	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.