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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 60 of 91
DeviceModel / ReferenceRegistriesClassStatus
Intensa 460-FS-AA-PS-PU
FDA UDI
Class IActive
Intensa IN577RGH401PA
FDA UDI
Class IActive
Hausted 4200-EO-WH
FDA UDI
Class IActive
Everest & Jennings 3G010330
FDA UDI
Class IActive
Intensa 744-T6
FDA UDI
Class IActive
Intensa IN577RGHSH
FDA UDI
Class IActive
Intensa 7408-B-VI
FDA UDI
Class IActive
Intensa IN587WWGPA
FDA UDI
Class IActive
Lumex FMC114
FDA UDI
Class IIActive
Labtron 602
FDA UDI
Class IActive
Lumex FR587WH9210PA
FDA UDI
Class IActive
Transfer Master B314-FSL
FDA UDI
Class IIActive
Lumex FR587WH1323
FDA UDI
Class IActive
Intensa IN566G9210
FDA UDI
Class IActive
Intensa 748CB-BU
FDA UDI
Class IActive
Everest & Jennings 907630B1A
FDA UDI
Class IActive
Lumex 750000P
FDA UDI
Class IIActive
Lumex FR587WDH8615PA
FDA UDI
Class IActive
Intensa 420-T7
FDA UDI
Class IActive
Intensa 460-FL-BU
FDA UDI
Class IActive
Intensa IN577RGH6717
FDA UDI
Class IActive
Intensa 748-T9
FDA UDI
Class IActive
Intensa 420-DW-T6
FDA UDI
Class IActive
Lumex FR566DG6725PA
FDA UDI
Class IActive
Intensa IN597GAQ
FDA UDI
Class IActive
Intensa 460-FS-AA-T7
FDA UDI
Class IActive
Everest & Jennings 90763040
FDA UDI
Class IActive
Everest & Jennings 90763160
FDA UDI
Class IUnknown
Lumex FR597P1311
FDA UDI
Class IActive
Intensa 420-DW-ST
FDA UDI
Class IActive
Intensa IN566GSH
FDA UDI
Class IActive
Intensa 460-DW-NO
FDA UDI
Class IActive
Lumex FR587WH1311
FDA UDI
Class IActive
Intensa 460-DW-PL
FDA UDI
Class IActive
Intensa IN566G1318PA
FDA UDI
Class IActive
Intensa IN601UHGR
FDA UDI
Class IActive
Intensa IN577RGH9208PA
FDA UDI
Class IActive
Everest & Jennings 8930206
FDA UDI
Class IActive
Intensa IN587W8584PA
FDA UDI
Class IActive
Grafco 2857
FDA UDI
Class IActive
Everest & Jennings 12202110
FDA UDI
Class IActive
Intensa IN597P6714
FDA UDI
Class IActive
Lumex DSHC70012
FDA UDI
Class IActive
Intensa IN587WDH1319
FDA UDI
Class IActive
Intensa 748-T5
FDA UDI
Class IActive
Lumex FR601PH427
FDA UDI
Class IActive
Hausted 4200-DW-WW
FDA UDI
Class IActive
Intensa 460-AA-DW-COM
FDA UDI
Class IActive
Hausted 6200DA-DO
FDA UDI
Class IActive
Intensa IN566GWH
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

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.