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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 21 of 91
DeviceModel / ReferenceRegistriesClassStatus
John Bunn 3255-4
FDA UDI
Class IIActive
Everest & Jennings 90763062
FDA UDI
Class IActive
Lumex FMC115
FDA UDI
Class IIActive
Lumex FR566G6725PA
FDA UDI
Class IActive
Basic American Medical Products ZZ9ASW
FDA UDI
Class IIActive
Intensa IN577RGH1311
FDA UDI
Class IActive
Hausted 4200-MO
FDA UDI
Class IActive
Intensa 610-T9
FDA UDI
Class IActive
Intensa IN601UMO
FDA UDI
Class IActive
Intensa 460-DW-T2
FDA UDI
Class IActive
Everest & Jennings 3E050130
FDA UDI
Class IActive
Grafco 2665
FDA UDI
Class IActive
Everest & Jennings 90763130
FDA UDI
Class IActive
Intensa IN587WDPU
FDA UDI
Class IActive
Lumex 574G401
FDA UDI
Class IActive
Lumex FR597P1325
FDA UDI
Class IActive
Grafco 2839
FDA UDI
Class IActive
Everest & Jennings 3G010440
FDA UDI
Class IActive
Grafco 2743
FDA UDI
Class IActive
Intensa IN597G-T2
FDA UDI
Class IActive
LabTron 202C
FDA UDI
Class IIActive
Lumex FR587WDH1325
FDA UDI
Class IActive
Gaham Field 201BK-C
FDA UDI
Class IIActive
Hausted 4600-AA-FS-AQ
FDA UDI
Class IActive
Intensa IN566G1311
FDA UDI
Class IActive
Everest & Jennings 3F012230
FDA UDI
Class IActive
Lumex FR597P9524
FDA UDI
Class IActive
Lumex FR577RGH9205PA
FDA UDI
Class IActive
Grafco 1197F#4
FDA UDI
Class IActive
Intensa IN577RGPUPA
FDA UDI
Class IActive
Everest & Jennings 3J010430
FDA UDI
Class IActive
Lumex FR565WG6727
FDA UDI
Class IActive
Hausted 4200-T2
FDA UDI
Class IActive
Intensa IN566GH409PA
FDA UDI
Class IActive
Hausted 4600-AA-AR
FDA UDI
Class IActive
Everest & Jennings 90763031
FDA UDI
Class IActive
Intensa IN566GHWG
FDA UDI
Class IActive
Intensa 748B-VI
FDA UDI
Class IActive
Everest & Jennings 90763042A
FDA UDI
Class IActive
Hausted 4600-AA-PS-BT
FDA UDI
Class IActive
Hausted 4200-NO
FDA UDI
Class IActive
Lumex FR566GH427
FDA UDI
Class IActive
Intensa IN587WH1315PA
FDA UDI
Class IActive
Intensa IN587WDHTLPA
FDA UDI
Class IActive
Grafco 2674
FDA UDI
Class IActive
Everest & Jennings 90763002A
FDA UDI
Class IActive
Intensa IN566GH401PA
FDA UDI
Class IActive
Hausted 4600-FS-DW-TL
FDA UDI
Class IActive
Intensa IN587WDH454
FDA UDI
Class IActive
Intensa 460-AA-PL
FDA UDI
Class IActive

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Authorised Representatives

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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.