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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 19 of 91
DeviceModel / ReferenceRegistriesClassStatus
Intensa 460-TL
FDA UDI
Class IActive
LabTron 200BK-I
FDA UDI
Class IIActive
Transfer Master B407-F84-C
FDA UDI
Class IIActive
Intensa 460-FS-AA-PS-VI
FDA UDI
Class IActive
Intensa 748B-AL
FDA UDI
Class IActive
Lumex FR587WD9201PA
FDA UDI
Class IActive
Intensa 7408-B-NA
FDA UDI
Class IActive
Intensa 420-EO-DW-T2
FDA UDI
Class IActive
Intensa IN566GHBTPA
FDA UDI
Class IActive
Hausted 4600-FS-DW-PL
FDA UDI
Class IActive
Everest & Jennings 90763565
FDA UDI
Class IActive
Everest & Jennings 90H35060J
FDA UDI
Class IActive
Lumex UPH863
FDA UDI
Class IActive
Intensa 460-FS-DW-PU
FDA UDI
Class IActive
Grafco 1821
FDA UDI
Class IActive
Intensa IN566DGHTEPA
FDA UDI
Class IActive
Intensa 744-WG
FDA UDI
Class IActive
Intensa IN577RGH9210
FDA UDI
Class IActive
Intensa IN566GPU
FDA UDI
Class IActive
Lumex FR577RGH409PA
FDA UDI
Class IActive
Intensa IN587WD8604PA
FDA UDI
Class IActive
Intensa IN566GH409
FDA UDI
Class IActive
Lumex FR587W6705PA
FDA UDI
Class IActive
Hausted 4600-FS-PS-ST
FDA UDI
Class IActive
Intensa 748CB-GR
FDA UDI
Class IActive
Intensa 744B-T5
FDA UDI
Class IActive
Transfer Master B306-T
FDA UDI
Class IIActive
Lumex 574G851
FDA UDI
Class IActive
Intensa IN566DGHWGPA
FDA UDI
Class IActive
Hausted 6200-BL
FDA UDI
Class IActive
Intensa 744B-WG-SW
FDA UDI
Class IActive
Lumex FR601UH1305
FDA UDI
Class IActive
Intensa 744CB-T1
FDA UDI
Class IActive
Lumex 8220166
FDA UDI
Class IActive
Intensa IN587WDH1323PA
FDA UDI
Class IActive
Intensa 460-AA-PS-T4
FDA UDI
Class IActive
Intensa IN587WHPUPA
FDA UDI
Class IActive
Intensa IN601UWH
FDA UDI
Class IActive
Intensa IN597G454
FDA UDI
Class IActive
Intensa 460-FS-ST
FDA UDI
Class IActive
Lumex FR597P9214
FDA UDI
Class IActive
Lumex FR565WG8611
FDA UDI
Class IActive
Intensa IN587WDPUPA
FDA UDI
Class IActive
Intensa 460-FS-AA-DB
FDA UDI
Class IActive
Intensa IN587WHAQPA
FDA UDI
Class IActive
Intensa 420-DW-T9
FDA UDI
Class IActive
Hausted 4600-FS-PS-PM
FDA UDI
Class IActive
Intensa IN566DG1323
FDA UDI
Class IActive
Intensa 420-ST
FDA UDI
Class IActive
Intensa IN587WH9214
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.