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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 1 of 91
DeviceModel / ReferenceRegistriesClassStatus
Intensa IN566GH8567PA
FDA UDI
Class IActive
Intensa IN597GAL
FDA UDI
Class IActive
Intensa IN566G6725PA
FDA UDI
Class IActive
Intensa 420-EO-T8
FDA UDI
Class IActive
Intensa IN597G9205
FDA UDI
Class IActive
Intensa IN587WH9205
FDA UDI
Class IActive
Intensa 460-PS-T7
FDA UDI
Class IActive
Intensa IN597PMO
FDA UDI
Class IActive
Lumex SAL1230-KB
FDA UDI
Class IActive
Hausted 4600-OG
FDA UDI
Class IActive
Intensa IN566G1323PA
FDA UDI
Class IActive
Graham Field 201BK
FDA UDI
Class IIActive
Gendron G1600
FDA UDI
Class IIActive
Grafco 3786-12#2
FDA UDI
Class IActive
Lumex FR566G6717PA
FDA UDI
Class IActive
Lumex LF1030S
FDA UDI
Class IActive
Intensa 620-DA-DB
FDA UDI
Class IActive
Intensa IN566GH9201
FDA UDI
Class IActive
Lumex FR588W863
FDA UDI
Class IActive
Lumex FR587WH9214
FDA UDI
Class IActive
Intensa IN601PHPL
FDA UDI
Class IActive
Basic American Medical Products APS78174
FDA UDI
Class IIActive
Intensa 460-DW-ST
FDA UDI
Class IActive
Transfer Master B306-FSL
FDA UDI
Class IIActive
Intensa IN577RGHNAPA
FDA UDI
Class IActive
Hausted 4600-AA-PS-DB
FDA UDI
Class IActive
Lumiscope 100-040P
FDA UDI
Class IIActive
Intensa IN587WSH
FDA UDI
Class IActive
Intensa IN566DG401PA
FDA UDI
Class IActive
Lumex DSC250
FDA UDI
Class IActive
Hausted 4200-BU
FDA UDI
Class IActive
Lumex FR566GH1305
FDA UDI
Class IActive
Lumex FR587WDH409PA
FDA UDI
Class IActive
Lumex FR601UH8615
FDA UDI
Class IActive
Lumex FR587WDH8516PA
FDA UDI
Class IActive
Intensa 460-AA-AR
FDA UDI
Class IActive
Lumex 2100A
FDA UDI
Class IActive
Intensa IN587WDH1304PA
FDA UDI
Class IActive
Intensa IN566DGNAPA
FDA UDI
Class IActive
Grafco 1305
FDA UDI
Class IActive
Lumiscope 1143
FDA UDI
Class IIActive
Hausted 4600-DW-BL
FDA UDI
Class IActive
Lumex FR587WH6705PA
FDA UDI
Class IActive
Lumex FR566DGH6717
FDA UDI
Class IActive
Lumex FR597G427
FDA UDI
Class IActive
Intensa 620-AR
FDA UDI
Class IActive
Intensa 744B-T2
FDA UDI
Class IActive
Grafco 9678
FDA UDI
Class IActive
Hausted 4600-FL-BT
FDA UDI
Class IActive
Lumex 2101A
FDA UDI
Class IActive

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Importers

Not available yet.

Notified Bodies

Not available yet.

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.