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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 30 of 91
DeviceModel / ReferenceRegistriesClassStatus
Everest & Jennings 9P835212J
FDA UDI
Class IActive
Intensa 744CB-AQ
FDA UDI
Class IActive
Intensa 7408-CB-TE
FDA UDI
Class IActive
LabTron V222B
FDA UDI
Class IIActive
Hausted 4200-EO-T2
FDA UDI
Class IActive
Lumex FR601PH1325
FDA UDI
Class IActive
Lumex FR565WG8516
FDA UDI
Class IActive
Hausted 4200-DW-NA
FDA UDI
Class IActive
Intensa IN566GHGR
FDA UDI
Class IActive
Transfer Master B407-T
FDA UDI
Class IIActive
Intensa IN566DGHAR
FDA UDI
Class IActive
Intensa IN587WD409PA
FDA UDI
Class IActive
Intensa 460-FS-AA-PS-PM
FDA UDI
Class IActive
Intensa IN566DG1318PA
FDA UDI
Class IActive
Intensa IN566GH6724
FDA UDI
Class IActive
Hausted 4600-AA-FS-WH
FDA UDI
Class IActive
Intensa IN577RGSHPA
FDA UDI
Class IActive
Intensa 460-PS-VI
FDA UDI
Class IActive
Intensa 460-AA-DW-DO
FDA UDI
Class IActive
Intensa IN601PH-COM
FDA UDI
Class IActive
Intensa IN587W1315PA
FDA UDI
Class IActive
Lumex FR577RG8604PA
FDA UDI
Class IActive
Intensa IN566GHVI
FDA UDI
Class IActive
Lumex FR577RGH8615PA
FDA UDI
Class IActive
Intensa 620-COM
FDA UDI
Class IActive
Lumex FR566DGH8805
FDA UDI
Class IUnknown
Intensa 460-FS-AA-VI
FDA UDI
Class IActive
Lumex FR587W8516PA
FDA UDI
Class IActive
Intensa IN566DGH9207PA
FDA UDI
Class IActive
Intensa IN577RGH9205
FDA UDI
Class IActive
Lumex FR597P6725
FDA UDI
Class IActive
Intensa IN566GNOPA
FDA UDI
Class IActive
Intensa IN577RG6705PA
FDA UDI
Class IActive
Lumex FR587WD1318PA
FDA UDI
Class IActive
Intensa 748CB-NO
FDA UDI
Class IActive
Intensa IN566DGTE
FDA UDI
Class IActive
Intensa IN597P9212
FDA UDI
Class IActive
Hausted 4600-PS-AR
FDA UDI
Class IActive
Intensa IN601PAL
FDA UDI
Class IActive
Intensa IN587WD8584PA
FDA UDI
Class IActive
Everest & Jennings 90763011A
FDA UDI
Class IActive
Intensa IN587WHBTPA
FDA UDI
Class IActive
Grafco 2612
FDA UDI
Class IActive
Intensa IN566DGMOPA
FDA UDI
Class IActive
Intensa IN577RGHVI
FDA UDI
Class IActive
Intensa IN587WDH6727
FDA UDI
Class IActive
Intensa IN597PBL
FDA UDI
Class IActive
John Bunn JB0150-086
FDA UDI
Class IActive
LabTron 242
FDA UDI
Class IIActive
Intensa IN577RG6725
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.