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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 77 of 91
DeviceModel / ReferenceRegistriesClassStatus
Intensa IN577RG1325PA
FDA UDI
Class IActive
Intensa 460-PS-T5
FDA UDI
Class IActive
John Bunn JB0112-071
FDA UDI
Class IIActive
Intensa 744-T8
FDA UDI
Class IActive
Grafco 1312-1
FDA UDI
Class IActive
Intensa 460-AA-PS-AQ
FDA UDI
Class IActive
Lumex FR587W6725PA
FDA UDI
Class IActive
Intensa IN601UDO
FDA UDI
Class IActive
Hausted 4200-DW-PM
FDA UDI
Class IActive
Everest and Jennings 90763053A
FDA UDI
Class IActive
Lumex FR577RG6705PA
FDA UDI
Class IActive
Lumex MC000481
FDA UDI
Class IActive
Lumex FR566DG9524
FDA UDI
Class IActive
Lumex FR597P8567
FDA UDI
Class IActive
John Bunn 1395-1#6
FDA UDI
Class IIActive
Grafco 2755
FDA UDI
Class IActive
Grafco 2686
FDA UDI
Class IActive
Grafco 1196FH
FDA UDI
Class IActive
Lumex FR587WDHO6727
FDA UDI
Class IActive
Intensa 460-AA-T4
FDA UDI
Class IActive
Intensa IN577RGT3
FDA UDI
Class IActive
Intensa IN587WDH9210PA
FDA UDI
Class IActive
Basic American Medical Products APS58674
FDA UDI
Class IIActive
Intensa IN566DGBUPA
FDA UDI
Class IActive
Hausted 4600-AA-FS-MO
FDA UDI
Class IActive
Hausted 4200-EO-WG
FDA UDI
Class IActive
Intensa 460-AA-PS-COM
FDA UDI
Class IActive
Basic American Medical Products ZZ9917448
FDA UDI
Class IIActive
Intensa 744CB-T2
FDA UDI
Class IActive
Everest & Jennings 907632C1A
FDA UDI
Class IActive
Hausted 4200-DO
FDA UDI
Class IActive
Lumex FR587WD1323PA
FDA UDI
Class IActive
Hausted 4600-AA-DW-BU
FDA UDI
Class IActive
Intensa IN587WD1325PA
FDA UDI
Class IActive
Intensa 460-FS-PU
FDA UDI
Class IActive
Intensa 460-FS-AA-PS-T9
FDA UDI
Class IActive
Lumex FR587WDH8516
FDA UDI
Class IActive
Intensa 620-T8
FDA UDI
Class IActive
Intensa IN587WD9205
FDA UDI
Class IActive
Lumex FR566DGH432PA
FDA UDI
Class IActive
Hausted 4600-AA-FS-NA
FDA UDI
Class IActive
Lumex FR566GH6724
FDA UDI
Class IActive
Intensa 620-DA-T8
FDA UDI
Class IActive
Intensa IN601PDB
FDA UDI
Class IActive
LabTron 180C
FDA UDI
Class IIActive
Hausted 4600-DW-PM
FDA UDI
Class IActive
Intensa IN566DGWWPA
FDA UDI
Class IActive
Intensa IN577RGHSHPA
FDA UDI
Class IActive
LabTron 240X
FDA UDI
Class IIActive
Intensa IN577RGARPA
FDA UDI
Class IActive

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Importers

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Notified Bodies

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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.