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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 22 of 91
DeviceModel / ReferenceRegistriesClassStatus
Grafco 2664
FDA UDI
Class IActive
Intensa 460-FS-AA-PS-BT
FDA UDI
Class IActive
Lumex FR587W6724PA
FDA UDI
Class IActive
Intensa IN587WH9212PA
FDA UDI
Class IActive
Lumex FR587WD9214PA
FDA UDI
Class IActive
Gendron TRC28750
FDA UDI
Class IActive
Lumex FR566DGH427
FDA UDI
Class IActive
Basic American Medical Products MZW49174
FDA UDI
Class IIActive
Everest & Jennings 8265166
FDA UDI
Class IActive
Intensa 460-AA-DW-T8
FDA UDI
Class IActive
Intensa IN587WHNO
FDA UDI
Class IActive
Hausted 6200DA-TL
FDA UDI
Class IActive
Lumex FR601PH8604
FDA UDI
Class IActive
Lumex FR566DGH1325
FDA UDI
Class IActive
Basic American Medical Products ZZ7SW
FDA UDI
Class IIActive
Lumex FR587WH6727
FDA UDI
Class IActive
Hausted 4200-EO-NA
FDA UDI
Class IActive
Intensa 460-AA-PS-OG
FDA UDI
Class IActive
Grafco 3786-12#3
FDA UDI
Class IActive
Lumex FR601UH427
FDA UDI
Class IActive
Everest & Jennings 8100208
FDA UDI
Class IActive
Intensa IN577RGHAR
FDA UDI
Class IActive
LabTron 180T
FDA UDI
Class IIActive
Intensa 748-WG-SBCSW
FDA UDI
Class IActive
Intensa IN597P1323
FDA UDI
Class IActive
Lumex FR565WG1318
FDA UDI
Class IActive
Intensa IN577RGDOPA
FDA UDI
Class IActive
Lumex FR577RGH6717PA
FDA UDI
Class IActive
Intensa 460-PS-AL
FDA UDI
Class IActive
Lumex FR587WD1319PA
FDA UDI
Class IActive
Intensa 420-DW-SH
FDA UDI
Class IActive
Intensa IN566DG9214PA
FDA UDI
Class IActive
Lumex FR587WH1323PA
FDA UDI
Class IActive
Lumex FR587WH8604
FDA UDI
Class IActive
Intensa IN566G6727PA
FDA UDI
Class IActive
Intensa IN597G6725
FDA UDI
Class IActive
Intensa IN566GHBUPA
FDA UDI
Class IActive
Intensa IN566GHARPA
FDA UDI
Class IActive
Hausted 4600-FS-AA-PS-AR
FDA UDI
Class IActive
Lumex FR566DGH1305PA
FDA UDI
Class IActive
Lumex FR566DGH9214PA
FDA UDI
Class IActive
John Bunn 3255-7
FDA UDI
Class IIActive
Lumex FR566DGH8604
FDA UDI
Class IActive
Hausted 4600-FS-AA-PS-BL
FDA UDI
Class IActive
Lumex FR601PH6717
FDA UDI
Class IActive
Lumex FR566DGH9205
FDA UDI
Class IActive
Intensa 620-T2
FDA UDI
Class IActive
Lumex FR597G8516
FDA UDI
Class IActive
Intensa 744CB-T6
FDA UDI
Class IActive
Hausted 4600-AA-DW-TL
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

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.