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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 35 of 91
DeviceModel / ReferenceRegistriesClassStatus
Everest & Jennings 907630C2A
FDA UDI
Class IActive
Intensa IN566GPMPA
FDA UDI
Class IActive
Intensa IN566DGHSH
FDA UDI
Class IActive
Intensa IN566DGH454
FDA UDI
Class IActive
Gendron PL800S
FDA UDI
Class IIActive
Intensa 460-AA-AQ
FDA UDI
Class IActive
Lumex 13635
FDA UDI
Class IActive
Intensa IN587WDCOM
FDA UDI
Class IActive
Intensa IN587W9208
FDA UDI
Class IActive
Hausted 6200DA-PL
FDA UDI
Class IActive
Intensa 460-FS-PS-T9
FDA UDI
Class IActive
Intensa IN587W1304PA
FDA UDI
Class IActive
Intensa 460-AA-DW-PL
FDA UDI
Class IActive
Intensa 420-EO-PU
FDA UDI
Class IActive
Intensa IN597POG
FDA UDI
Class IActive
Hausted 6200-PU
FDA UDI
Class IActive
Intensa IN587WH8602
FDA UDI
Class IActive
Intensa 460-PS-T1
FDA UDI
Class IActive
John Bunn GF64041
FDA UDI
Class IActive
Hausted 4600-AA-FS-PM
FDA UDI
Class IActive
Intensa 460-FL-NO
FDA UDI
Class IActive
Intensa IN577RG8602PA
FDA UDI
Class IActive
Intensa IN577RG432
FDA UDI
Class IActive
Intensa IN577RGH1315
FDA UDI
Class IActive
Everest & Jennings 8565188
FDA UDI
Class IActive
Hausted 4200-DW-AR
FDA UDI
Class IActive
Everest & Jennings 90763650
FDA UDI
Class IActive
Intensa IN566DGSTPA
FDA UDI
Class IActive
Intensa IN566DG432PA
FDA UDI
Class IActive
Intensa IN601UHST
FDA UDI
Class IActive
Intensa IN587WDHMO
FDA UDI
Class IActive
Gendron GS4748SB
FDA UDI
Class IIActive
Intensa 460-AA-PS-BU
FDA UDI
Class IActive
Hausted 4600-FS-GR
FDA UDI
Class IActive
Intensa 460-T2-AA-DW-PS
FDA UDI
Class IActive
Hausted 4600-FL-PL
FDA UDI
Class IActive
Hausted 6200DA-GR
FDA UDI
Class IActive
Lumex FR587WH6725
FDA UDI
Class IActive
Intensa IN566GWGPA
FDA UDI
Class IActive
Everest & Jennings 9P835230J
FDA UDI
Class IActive
Intensa 620-GR
FDA UDI
Class IActive
Intensa IN587W409
FDA UDI
Class IActive
Hausted 4600-FS-PS-BT
FDA UDI
Class IActive
Hausted 4600-DW-WG
FDA UDI
Class IActive
Gendron RG800A
FDA UDI
Class IIActive
Everest & Jennings 90763066
FDA UDI
Class IActive
Lumex FR566DGH8533
FDA UDI
Class IUnknown
Intensa IN566DGH8604PA
FDA UDI
Class IActive
Intensa 748CB-T1
FDA UDI
Class IActive
Hausted 4600-DW-DO
FDA UDI
Class IActive

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Importers

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Authorities

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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.

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.