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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 70 of 91
DeviceModel / ReferenceRegistriesClassStatus
Labtron 1227-1
FDA UDI
Class IActive
Hausted 6200-BT
FDA UDI
Class IActive
Intensa IN601UH-T3
FDA UDI
Class IActive
Lumex FR566G9517
FDA UDI
Class IActive
Lumex F117
FDA UDI
Class IIActive
Intensa 748CB-SH
FDA UDI
Class IActive
Hausted 4600-AA-DW-SH
FDA UDI
Class IActive
Intensa IN566G454
FDA UDI
Class IActive
Transfer Master B314-TSL
FDA UDI
Class IIActive
Basic American Medical Products ZG78674
FDA UDI
Class IIActive
Hausted 4600-FS-PS-NA
FDA UDI
Class IActive
Intensa 460-FS-PS-TE
FDA UDI
Class IActive
Everest & Jennings 9P835216J
FDA UDI
Class IActive
Intensa 744CB-WG
FDA UDI
Class IActive
Intensa 460-FS-AA-NA
FDA UDI
Class IActive
Lumex FR601UH1319
FDA UDI
Class IActive
Everest & Jennings 3H020330
FDA UDI
Class IActive
Intensa IN566G9208
FDA UDI
Class IActive
Intensa IN566GHBU
FDA UDI
Class IActive
Intensa IN566DGST
FDA UDI
Class IActive
Intensa 748CB-T6
FDA UDI
Class IActive
Lumex FR587WDH9212PA
FDA UDI
Class IActive
Hausted 4600-FS-PS-OG
FDA UDI
Class IActive
Intensa IN587WDB
FDA UDI
Class IActive
Intensa 748-OG
FDA UDI
Class IActive
Hausted 4600-DW-BT
FDA UDI
Class IActive
Intensa 420-DW-WG
FDA UDI
Class IActive
Lumex 750000
FDA UDI
Class IIActive
Intensa 460-DW-T10
FDA UDI
Class IActive
Lumex FR597G9212
FDA UDI
Class IActive
Intensa IN587WDHPM
FDA UDI
Class IActive
Lumex 7921RA
FDA UDI
Class IActive
Intensa IN587WDH8567PA
FDA UDI
Class IActive
Intensa IN566GHWHPA
FDA UDI
Class IActive
Lumex FR565WG9214
FDA UDI
Class IActive
Hausted 4600-AA-BU
FDA UDI
Class IActive
Everest & Jennings 907632A3A
FDA UDI
Class IActive
Lumex ABL-B700
FDA UDI
Class IIActive
Intensa IN566DGH432PA
FDA UDI
Class IActive
Intensa 460-FS-AA-MO
FDA UDI
Class IActive
Lumex FR597G1325
FDA UDI
Class IActive
Intensa 420-DW-VI
FDA UDI
Class IActive
Everest & Jennings EJ790-1
FDA UDI
Class IActive
Hausted 4600-PS-PL
FDA UDI
Class IActive
Lumex FR587W1305PA
FDA UDI
Class IActive
Grafco 2805
FDA UDI
Class IActive
Lumex LF1031MS
FDA UDI
Class IActive
Intensa IN566DGSHPA
FDA UDI
Class IActive
Intensa IN601PBU
FDA UDI
Class IActive
Hausted 4600-FS-AA-PS-OG
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.