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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 54 of 91
DeviceModel / ReferenceRegistriesClassStatus
Everest & Jennings EJ78-SEAT19A
FDA UDI
Class IActive
Grafco 3786B#1
FDA UDI
Class IActive
Hausted 4600-PS-DO
FDA UDI
Class IActive
Lumex MS883
FDA UDI
Class IActive
Lumex FR566DGH9201
FDA UDI
Class IActive
Intensa 744-MO
FDA UDI
Class IActive
Intensa 460-WG
FDA UDI
Class IActive
Lumiscope 2215
FDA UDI
Class IIActive
Intensa IN587WDGRPA
FDA UDI
Class IActive
Lumex FR601PH1304
FDA UDI
Class IActive
Intensa 460-DW-WG
FDA UDI
Class IActive
Lumex FR587WDH1311PA
FDA UDI
Class IActive
Intensa 460-DW-T3
FDA UDI
Class IActive
Hausted 4600-FS-PS-TL
FDA UDI
Class IActive
Intensa 460-FS-AA-PS-DB
FDA UDI
Class IActive
Intensa IN587WHFCTE
FDA UDI
Class IActive
Everest & Jennings 90763030
FDA UDI
Class IActive
Intensa 744CB-BU
FDA UDI
Class IActive
Grafco 4001GF
FDA UDI
Class IIActive
Intensa 460-FL-ST
FDA UDI
Class IActive
Intensa 460-AA-T9
FDA UDI
Class IActive
Intensa IN566DGNOPA
FDA UDI
Class IActive
Intensa 7408-B-AQ
FDA UDI
Class IActive
Intensa 460-FS-AA-PS-PL
FDA UDI
Class IActive
Hausted 6200DA-PU
FDA UDI
Class IActive
Lumex FR587WH454PA
FDA UDI
Class IActive
Everest & Jennings 3H021330
FDA UDI
Class IActive
Intensa IN566DGNA
FDA UDI
Class IActive
Lumex FR577RGH6727PA
FDA UDI
Class IActive
Lumex 8565208CS
FDA UDI
Class IActive
Intensa 744-AR
FDA UDI
Class IActive
Everest & Jennings 90H35081J
FDA UDI
Class IActive
Intensa IN566DGGRPA
FDA UDI
Class IActive
Hausted 4600-FS-DO
FDA UDI
Class IActive
Lumex FR587WH6717
FDA UDI
Class IActive
Lumex FR577RGH9205
FDA UDI
Class IActive
Intensa IN577RGH6714
FDA UDI
Class IActive
Intensa 7408-CB-PL
FDA UDI
Class IActive
Intensa 460-NA
FDA UDI
Class IActive
Intensa IN587WDH8602PA
FDA UDI
Class IActive
Everest & Jennings 3E050140
FDA UDI
Class IActive
Everest & Jennings 3G010340
FDA UDI
Class IActive
Intensa 460-AA-PS-NA
FDA UDI
Class IActive
Intensa 610-TL
FDA UDI
Class IActive
Grafco 3789
FDA UDI
Class IIActive
Hausted 4600-FL-NO
FDA UDI
Class IActive
Intensa IN587WHAR
FDA UDI
Class IActive
Intensa IN566DGHSHPA
FDA UDI
Class IActive
Lumex FR597G1311
FDA UDI
Class IActive
Intensa IN566GH432
FDA UDI
Class IActive

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Authorised Representatives

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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.