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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 81 of 91
DeviceModel / ReferenceRegistriesClassStatus
Intensa IN566DG6724PA
FDA UDI
Class IActive
Intensa IN587WD401PA
FDA UDI
Class IActive
Intensa T9
FDA UDI
Class IActive
Hausted 6200-PM
FDA UDI
Class IActive
Everest & Jennings 90763033A
FDA UDI
Class IActive
Intensa 748B-DB
FDA UDI
Class IActive
Intensa 744B-T7
FDA UDI
Class IActive
Lumex FR566G9516
FDA UDI
Class IActive
Lumex FR601PH9208
FDA UDI
Class IActive
Lumex FR597G9201
FDA UDI
Class IActive
Lumex FR587W6714PA
FDA UDI
Class IActive
Hausted 4200-DW-GR
FDA UDI
Class IActive
Transfer Master B306-F
FDA UDI
Class IIActive
Intensa IN587WD432
FDA UDI
Class IActive
Intensa IN587WD8615
FDA UDI
Class IActive
Lumex FR597P401
FDA UDI
Class IActive
Lumex FR566DGH9207
FDA UDI
Class IActive
Intensa 460-PS-BU
FDA UDI
Class IActive
Basic American Medical Products ZZ99174
FDA UDI
Class IIActive
Hausted 4600-FS-WG
FDA UDI
Class IActive
Lumex FR587W8584PA
FDA UDI
Class IActive
Intensa IN566G427PA
FDA UDI
Class IActive
Intensa IN577RGNA
FDA UDI
Class IActive
Intensa IN587WH8584
FDA UDI
Class IActive
Lumex FR566GH9214
FDA UDI
Class IActive
Intensa 460-AA-PS-BT
FDA UDI
Class IActive
Intensa IN566GWW
FDA UDI
Class IActive
Everest & Jennings 90763063A
FDA UDI
Class IActive
Hausted 4200-EO-DO
FDA UDI
Class IActive
Intensa IN587WH1319
FDA UDI
Class IActive
Intensa IN597PTL
FDA UDI
Class IActive
Intensa IN601UPM
FDA UDI
Class IActive
Everest & Jennings 8940188
FDA UDI
Class IActive
Intensa 460-PS-AR
FDA UDI
Class IActive
Gendron GS4842DW
FDA UDI
Class IIActive
Intensa 460-FS-DW-T1
FDA UDI
Class IActive
Basic American Medical Products ZG7SW
FDA UDI
Class IIActive
Intensa 460-FS-PS-T10
FDA UDI
Class IActive
LUMEX Essentials 81228
FDA UDI
Class IActive
Intensa 460-FS-AA-PS-T7
FDA UDI
Class IActive
Intensa IN566DGVIPA
FDA UDI
Class IActive
Intensa IN577RGHPL
FDA UDI
Class IActive
Intensa 460-FS-AR
FDA UDI
Class IActive
Intensa IN566G8602PA
FDA UDI
Class IActive
Intensa 460-T9
FDA UDI
Class IActive
Everest & Jennings EJ791-1
FDA UDI
Class IActive
Intensa IN566GTL
FDA UDI
Class IActive
Intensa IN566DGDOPA
FDA UDI
Class IActive
Intensa 744CB-SH
FDA UDI
Class IActive
Intensa 748B-GR-SW
FDA UDI
Class IActive

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No authorised representatives on record.

Importers

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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.