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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 76 of 91
DeviceModel / ReferenceRegistriesClassStatus
Hausted 6200-TE
FDA UDI
Class IActive
Intensa 460-FL-AL
FDA UDI
Class IActive
Intensa 420-EO-PM
FDA UDI
Class IActive
Everest & Jennings 90763SE18
FDA UDI
Class IActive
Hausted 4200-EO-AL
FDA UDI
Class IActive
Intensa IN577RGHBUPA
FDA UDI
Class IActive
Lumex FR566DGH8567PA
FDA UDI
Class IActive
Intensa 744-BL-SW
FDA UDI
Class IActive
Intensa IN601PHAR
FDA UDI
Class IActive
Transfer Master B306-TSL
FDA UDI
Class IIActive
Intensa IN587WD9208PA
FDA UDI
Class IActive
Lumex FR577RGH8516
FDA UDI
Class IActive
Lumex FR587WD9207PA
FDA UDI
Class IActive
Intensa 744-T9
FDA UDI
Class IActive
Hausted 4600-FS-BU
FDA UDI
Class IActive
Lumex FR601PH9212
FDA UDI
Class IActive
Intensa 420-DW-TE
FDA UDI
Class IActive
Hausted 4600-AA-DW-AL
FDA UDI
Class IActive
Lumex 774200AP
FDA UDI
Class IIActive
Grafco 2858
FDA UDI
Class IActive
Intensa 748-SH-SW
FDA UDI
Class IActive
Grafco 2302-B
FDA UDI
Class IActive
Intensa IN577RGH9212
FDA UDI
Class IActive
Grafco 2705
FDA UDI
Class IActive
Lumex FR566DGH8516
FDA UDI
Class IActive
Lumex FR577RGHO427PA
FDA UDI
Class IActive
Intensa IN577RG9207PA
FDA UDI
Class IActive
Intensa 744B-TL
FDA UDI
Class IActive
Intensa 748-DB
FDA UDI
Class IActive
Lumex FR601PH1318
FDA UDI
Class IActive
Intensa IN597G1311
FDA UDI
Class IActive
Intensa 460-FS-SH
FDA UDI
Class IActive
Everest & Jennings 90763155
FDA UDI
Class IActive
Intensa IN566DGH1315PA
FDA UDI
Class IActive
Lumex FR565WG8604
FDA UDI
Class IActive
Intensa IN587WDAR
FDA UDI
Class IActive
Intensa IN577RGOG
FDA UDI
Class IActive
Lumex FR601PH9613
FDA UDI
Class IActive
Lumex FR577RGH427PA
FDA UDI
Class IActive
Lumex FR601UHO427
FDA UDI
Class IActive
Grafco GF-3T
FDA UDI
Class IIActive
Hausted 4600-FS-WH
FDA UDI
Class IActive
Intensa 460-AA-PS-SH
FDA UDI
Class IActive
Intensa IN577RGH8516
FDA UDI
Class IActive
Intensa 460-AA-AL
FDA UDI
Class IActive
Intensa IN587WDH9207
FDA UDI
Class IActive
Intensa IN601UHVI
FDA UDI
Class IActive
Intensa IN597G1304
FDA UDI
Class IActive
Intensa IN601UHPU
FDA UDI
Class IActive
Intensa 420-DW-T5
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.