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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 82 of 91
DeviceModel / ReferenceRegistriesClassStatus
Intensa IN587WDST
FDA UDI
Class IActive
Intensa 460-FS-PS-TL
FDA UDI
Class IActive
Intensa IN566G1319PA
FDA UDI
Class IActive
Labtron 400BL
FDA UDI
Class IActive
Intensa IN566DGH1323PA
FDA UDI
Class IActive
Intensa 748CB-BL
FDA UDI
Class IActive
Everest & Jennings 3H020220
FDA UDI
Class IActive
Intensa IN566DG6725
FDA UDI
Class IActive
Everest & Jennings PT3000-18
FDA UDI
Class IActive
Intensa IN597GWW
FDA UDI
Class IActive
Intensa 620-DA-PU
FDA UDI
Class IActive
Basic American Medical Products ZZA99674-897
FDA UDI
Class IIActive
Intensa IN566DG8584
FDA UDI
Class IActive
Intensa 420-DW-T1
FDA UDI
Class IActive
Intensa 744B-NA
FDA UDI
Class IActive
Intensa IN601PHPU
FDA UDI
Class IActive
Intensa IN587WBUPA
FDA UDI
Class IActive
Intensa 460-FS-WW
FDA UDI
Class IActive
Intensa 620-DA-NO
FDA UDI
Class IActive
LabTron 200X
FDA UDI
Class IIActive
John Bunn GF61399
FDA UDI
Class IIActive
LabTron 222
FDA UDI
Class IIActive
Intensa 460-FS-PL
FDA UDI
Class IActive
Intensa IN587WDH9208PA
FDA UDI
Class IActive
Grafco 1799-9133
FDA UDI
NActive
Intensa IN587W1325PA
FDA UDI
Class IActive
Intensa 460-DW-WW
FDA UDI
Class IActive
Everest & Jennings 3G010420
FDA UDI
Class IActive
Everest & Jennings 3E050220
FDA UDI
Class IActive
Intensa IN587WDO
FDA UDI
Class IActive
Intensa IN587W9207
FDA UDI
Class IActive
LabTron 200C
FDA UDI
Class IIActive
Grafco 3918-1
FDA UDI
Class IActive
Intensa 420-EO-T7
FDA UDI
Class IActive
Intensa 460-DW-DO
FDA UDI
Class IActive
Intensa 420-TE
FDA UDI
Class IActive
Intensa IN597P6727
FDA UDI
Class IActive
Intensa 620-T10
FDA UDI
Class IActive
Intensa 748-AR
FDA UDI
Class IActive
Intensa IN566DGH409PA
FDA UDI
Class IActive
Intensa IN601PST
FDA UDI
Class IActive
Intensa IN577RG1325
FDA UDI
Class IActive
Everest & Jennings EJ78-CST-FAA
FDA UDI
Class IActive
Grafco 1565 3
FDA UDI
Class IActive
Intensa IN577RGNOPA
FDA UDI
Class IActive
Intensa IN597PWH
FDA UDI
Class IActive
Everest & Jennings 90763001A
FDA UDI
Class IActive
Basic American Medical Products ZG58174
FDA UDI
Class IIActive
Intensa IN577RGH9210PA
FDA UDI
Class IActive
Grafco C100
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.