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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 9 of 91
DeviceModel / ReferenceRegistriesClassStatus
Grafco 3953 1/4
FDA UDI
Class IActive
Grafco 1565C-4
FDA UDI
Class IActive
Hausted 4600-FS-AA-PS-ST
FDA UDI
Class IActive
Grafco 3855
FDA UDI
Class IActive
Everest & Jennings 907630B2A
FDA UDI
Class IActive
Intensa IN601PHTL
FDA UDI
Class IActive
Everest & Jennings 90763SE20
FDA UDI
Class IActive
Intensa IN587W6724PA
FDA UDI
Class IActive
Hausted 4200-WW
FDA UDI
Class IActive
Lumex FR566DG8584PA
FDA UDI
Class IActive
Intensa IN577RGHDOPA
FDA UDI
Class IActive
Intensa IN597PBT
FDA UDI
Class IActive
Intensa IN566DGHBT
FDA UDI
Class IActive
Intensa IN587WPU
FDA UDI
Class IActive
John Bunn JB02008
FDA UDI
Class IIActive
Intensa 460-AA-DW-T9
FDA UDI
Class IActive
Intensa IN587WHPM
FDA UDI
Class IActive
Lumex FR577RGH6725
FDA UDI
Class IActive
Grafco 2712
FDA UDI
Class IActive
Intensa 460-FS-AA-PS-COM
FDA UDI
Class IActive
Intensa IN566GH1304PA
FDA UDI
Class IActive
Lumex LF2090-DSLSA3
FDA UDI
Class IActive
Lumex 7108A
FDA UDI
Class IActive
Lumex FR566GH8604
FDA UDI
Class IActive
LabTron 205
FDA UDI
Class IIActive
Intensa 460-ST
FDA UDI
Class IActive
Lumex FR566GH9205
FDA UDI
Class IActive
Lumex MS882
FDA UDI
Class IActive
Labtron 602N-P
FDA UDI
Class IActive
Intensa IN587WH8567PA
FDA UDI
Class IActive
Intensa 460-FL-AR
FDA UDI
Class IActive
Lumex FR566DGH432
FDA UDI
Class IActive
Grafco 2730
FDA UDI
Class IActive
Everest & Jennings 9P835232J
FDA UDI
Class IActive
Lumex FR566DGH454PA
FDA UDI
Class IActive
Intensa IN577RG401
FDA UDI
Class IActive
Lumiscope L2013BULK
FDA UDI
Class IIActive
Gendron GT5XLC
FDA UDI
Class IIActive
John Bunn JB0150-083
FDA UDI
Class IActive
Hausted 4600-AA-BT
FDA UDI
Class IActive
Hausted 4600-AA-PS-TE
FDA UDI
Class IActive
Intensa 7408-B-OG
FDA UDI
Class IActive
Intensa IN565WG409
FDA UDI
Class IActive
Everest & Jennings 90H43170J
FDA UDI
Class IActive
Transfer Master B407-T84
FDA UDI
Class IIActive
Intensa 460-PS-T6
FDA UDI
Class IActive
Intensa 748-COM-BCSW
FDA UDI
Class IActive
Intensa 748-ST
FDA UDI
Class IActive
Intensa IN601UHDB
FDA UDI
Class IActive
Everest & Jennings 3E050250
FDA UDI
Class IActive

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Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

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.