Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

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 87 of 91
DeviceModel / ReferenceRegistriesClassStatus
Everest & Jennings 90763022A
FDA UDI
Class IActive
Intensa IN566DGH9207
FDA UDI
Class IActive
Intensa 460-DW-DB
FDA UDI
Class IActive
Intensa IN566GHDO
FDA UDI
Class IActive
Everest & Jennings EJ792-1
FDA UDI
Class IActive
Grafco 1196H
FDA UDI
Class IActive
Intensa 460-FS-WG
FDA UDI
Class IActive
Intensa IN566GH6714PA
FDA UDI
Class IActive
Intensa 460-FS-T7
FDA UDI
Class IActive
Basic American Medical Products ZZ98174
FDA UDI
Class IIActive
Intensa IN566GBTPA
FDA UDI
Class IActive
Intensa 744-COM
FDA UDI
Class IActive
Intensa IN566GHALPA
FDA UDI
Class IActive
Intensa IN587W8516
FDA UDI
Class IActive
Intensa IN566GTLPA
FDA UDI
Class IActive
Grafco 2678
FDA UDI
Class IActive
Gendron G1050
FDA UDI
Class IIActive
Intensa IN601PVI
FDA UDI
Class IActive
Lumiscope 100-040BK
FDA UDI
Class IIActive
Intensa IN566DGBTPA
FDA UDI
Class IActive
Everest & Jennings 90763441
FDA UDI
Class IUnknown
Intensa IN587WDHALPA
FDA UDI
Class IActive
Intensa 460-PS-BT
FDA UDI
Class IActive
Intensa IN587WWHPA
FDA UDI
Class IActive
Intensa IN587W1305
FDA UDI
Class IActive
Intensa IN587WDH6725
FDA UDI
Class IActive
Intensa IN597PAL
FDA UDI
Class IActive
Intensa IN597P9201
FDA UDI
Class IActive
Grafco 3918-3
FDA UDI
Class IActive
Everest & Jennings EJ78-FRBLUEA
FDA UDI
Class IActive
Intensa IN566GH1305
FDA UDI
Class IActive
Everest & Jennings EJ78-FRSILVERA
FDA UDI
Class IActive
Intensa IN587WDH8516PA
FDA UDI
Class IActive
Labtron 540
FDA UDI
Class IActive
Intensa 748-NA
FDA UDI
Class IActive
Intensa 460-DW-AL
FDA UDI
Class IActive
Intensa 460-FS-BL
FDA UDI
Class IActive
Intensa IN587WDAL
FDA UDI
Class IActive
Lumiscope 1103
FDA UDI
Class IIActive
Intensa IN566DGALPA
FDA UDI
Class IActive
Lumiscope LUMI-TENS
FDA UDI
Class IIActive
Intensa IN597GTE
FDA UDI
Class IActive
Intensa IN566DGNO
FDA UDI
Class IActive
Intensa IN597GWG
FDA UDI
Class IActive
Intensa 744-NO
FDA UDI
Class IActive
Intensa 460-T8
FDA UDI
Class IActive
Intensa 460-AA-DW-AR
FDA UDI
Class IActive
Intensa IN587WWW
FDA UDI
Class IActive
Intensa 460-PS-WG
FDA UDI
Class IActive
Intensa IN587WDH1315
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

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.