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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
LinkedIn
—
Facebook
—
Phone
+17703684700
PRRC Contact
Amy Piccini
EUDAMED SRN
US-MF-000002167
FDA FEI Number
2427360
DUNS Number
—

Catalogue (4538)

Page 26 of 91
DeviceModel / ReferenceRegistriesClassStatus
Everest & Jennings 9P123011J
FDA UDI
Class IActive
Lumex FR566G1304
FDA UDI
Class IActive
Hausted 4600-FL-WG
FDA UDI
Class IActive
Gendron GS3648B
FDA UDI
Class IIActive
Intensa IN577RGBTPA
FDA UDI
Class IActive
Lumex FR587WH432PA
FDA UDI
Class IActive
Lumex FR601PH9214
FDA UDI
Class IActive
Lumex FR565WG1315
FDA UDI
Class IActive
Lumex FR566G6724PA
FDA UDI
Class IActive
Grafco 2764
FDA UDI
Class IActive
Lumex FR587WH6714
FDA UDI
Class IActive
Intensa IN566DGH454PA
FDA UDI
Class IActive
Hausted 4600-FL-PM
FDA UDI
Class IActive
Lumex FR601PLHO9611
FDA UDI
Class IActive
Intensa IN566GHNO
FDA UDI
Class IActive
Intensa IN566GAR
FDA UDI
Class IActive
Intensa IN601PHDO
FDA UDI
Class IActive
Intensa IN587WHMOPA
FDA UDI
Class IActive
Grafco 1196F#1
FDA UDI
Class IActive
Gendron 7155P180
FDA UDI
Class IActive
Intensa IN566G1323
FDA UDI
Class IActive
Intensa IN577RG6724
FDA UDI
Class IActive
Lumex FR577RGH6727
FDA UDI
Class IActive
Intensa IN601PHPM
FDA UDI
Class IActive
Everest & Jennings 90763012A
FDA UDI
Class IActive
LUMEX Essentials 81248
FDA UDI
Class IActive
Lumex 822019
FDA UDI
Class IActive
Hausted 4600-FL-WW
FDA UDI
Class IActive
Intensa 620-ST
FDA UDI
Class IActive
Everest & Jennings 8565248
FDA UDI
Class IActive
Lumex 574G409
FDA UDI
Class IActive
Hausted 4600-AA-PS-PM
FDA UDI
Class IActive
Intensa 7408-B-WG
FDA UDI
Class IActive
Labtron 711
FDA UDI
Class IActive
Lumex 8200
FDA UDI
Class IActive
Intensa IN587WH1325
FDA UDI
Class IActive
Labtron 722B
FDA UDI
Class IActive
Intensa IN577RG8567PA
FDA UDI
Class IActive
Intensa 748CB-DO
FDA UDI
Class IActive
Lumex FR566DGH9210
FDA UDI
Class IActive
Intensa 460-FS-WH
FDA UDI
Class IActive
Lumex FR601PLHO1323
FDA UDI
Class IActive
Intensa IN587WH6714
FDA UDI
Class IActive
Lumex FR577RGH401
FDA UDI
Class IActive
Intensa IN566GH8516
FDA UDI
Class IActive
Intensa IN597P-T3
FDA UDI
Class IActive
Intensa IN566GSHPA
FDA UDI
Class IActive
Lumex FR577RGH454PA
FDA UDI
Class IActive
Lumex FR566DGH6725
FDA UDI
Class IActive
Hausted 4600-FS-PU
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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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.

DateRecall No.ClassStatusReason
Mar 24, 2021Z-1353-2021—terminated

The front casters on the 6810A Lumex Drop Arm Versamode are incorrect.

Sep 30, 2016Z-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, 2009Z-0139-2010—terminated

Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.