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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 20 of 91
DeviceModel / ReferenceRegistriesClassStatus
Everest & Jennings 5PX10630
FDA UDI
Class IActive
Intensa IN566DG401
FDA UDI
Class IActive
Hausted 4600-AA-FS-ST
FDA UDI
Class IActive
Intensa IN577RGH9207PA
FDA UDI
Class IActive
Lumex FR587WH1318PA
FDA UDI
Class IActive
Everest & Jennings 8920186
FDA UDI
Class IActive
Lumex FR565WG9212
FDA UDI
Class IActive
Intensa 460-FS-AA-PS-AQ
FDA UDI
Class IActive
Hausted 4600-DW-TE
FDA UDI
Class IActive
Intensa IN577RG8604
FDA UDI
Class IActive
Intensa 744-VI
FDA UDI
Class IActive
Intensa 460-FL-OG
FDA UDI
Class IActive
Intensa IN587WH6705
FDA UDI
Class IActive
Intensa IN597P-T2
FDA UDI
Class IActive
Lumex FR587WDH9210
FDA UDI
Class IActive
Basic American Medical Products ZZ7ASW
FDA UDI
Class IIActive
Lumex FR587WDH8584
FDA UDI
Class IActive
Lumex FR566DG427PA
FDA UDI
Class IActive
Intensa 744-TL
FDA UDI
Class IActive
Intensa IN587WDH8584
FDA UDI
Class IActive
Intensa IN587WD9207
FDA UDI
Class IActive
Grafco 2611
FDA UDI
Class IActive
Intensa IN566GH1315
FDA UDI
Class IActive
Grafco 2623
FDA UDI
Class IActive
Intensa IN566DGH9208
FDA UDI
Class IActive
Hausted 4600-AA-FS-BU
FDA UDI
Class IActive
Lumex 8565186CS
FDA UDI
Class IActive
Lumex FR601PH1305
FDA UDI
Class IActive
Intensa 460-FL-BT
FDA UDI
Class IActive
Intensa IN566G6714
FDA UDI
Class IActive
Hausted 4600-FS-PS-WW
FDA UDI
Class IActive
Intensa IN587WDBUPA
FDA UDI
Class IActive
Lumex FR587WDH1323
FDA UDI
Class IActive
Hausted 4600-FS-NA
FDA UDI
Class IActive
Lumex 89180-4L
FDA UDI
Class IActive
Grafco 2652
FDA UDI
Class IActive
Lumex FR577RGHO401PA
FDA UDI
Class IActive
Intensa IN587WD9210
FDA UDI
Class IActive
Intensa IN566G8567PA
FDA UDI
Class IActive
Intensa 420-EO-VI
FDA UDI
Class IActive
Hausted 4600-PS-BL
FDA UDI
Class IActive
Intensa 460-PS-TL
FDA UDI
Class IActive
Hausted 4600-PU
FDA UDI
Class IActive
Intensa IN566GH9208PA
FDA UDI
Class IActive
Lumex FR587WDH9205PA
FDA UDI
Class IActive
Lumex FR587W9611
FDA UDI
Class IActive
Lumex FR587W409PA
FDA UDI
Class IActive
Intensa 460-SH
FDA UDI
Class IActive
Lumex FR587WDH1319
FDA UDI
Class IActive
Intensa IN566DG6714PA
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.