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 17 of 91
DeviceModel / ReferenceRegistriesClassStatus
Hausted 4600-FL-GR
FDA UDI
Class IActive
Intensa IN587WD9208
FDA UDI
Class IActive
Intensa IN587WDNA
FDA UDI
Class IActive
Intensa IN587WTLPA
FDA UDI
Class IActive
Basic American Medical Products APS981742
FDA UDI
Class IIActive
Intensa 420-EO-T10
FDA UDI
Class IActive
Lumex FR597P9212
FDA UDI
Class IActive
Lumex FR597G432
FDA UDI
Class IActive
Intensa 620-DA-BT
FDA UDI
Class IActive
Intensa 460-T7
FDA UDI
Class IActive
LabTron 180I
FDA UDI
Class IIActive
Intensa 420-T4
FDA UDI
Class IActive
Lumex FR577RG6725PA
FDA UDI
Class IActive
Intensa IN597PPU
FDA UDI
Class IActive
Lumex FR587WDH8602
FDA UDI
Class IActive
Lumex FR566DG6727PA
FDA UDI
Class IActive
Intensa IN577RGHWGPA
FDA UDI
Class IActive
Lumex FR601UH9212
FDA UDI
Class IActive
Intensa IN566DG1315
FDA UDI
Class IActive
Hausted 4200-EO-BU
FDA UDI
Class IActive
Lumex FR577RGH432PA
FDA UDI
Class IActive
Intensa IN566GOGPA
FDA UDI
Class IActive
Lumex FR587WH9208
FDA UDI
Class IActive
Lumex FR566GH6727
FDA UDI
Class IActive
Lumex FR597G9210
FDA UDI
Class IActive
Intensa 420-WH
FDA UDI
Class IActive
Intensa 620L-SH
FDA UDI
Class IActive
Transfer Master MLB-T-HL
FDA UDI
Class IIActive
Hausted 4600-PS-TL
FDA UDI
Class IActive
Intensa IN577RG432PA
FDA UDI
Class IActive
Lumex FR566DG9205PA
FDA UDI
Class IActive
Intensa 748B-T8
FDA UDI
Class IActive
Intensa 460-PS-COM
FDA UDI
Class IActive
Intensa 460-PS-T4
FDA UDI
Class IActive
Intensa IN577RGAL
FDA UDI
Class IActive
Lumex FR566DGH8584PA
FDA UDI
Class IActive
Intensa IN566DGH6724PA
FDA UDI
Class IActive
Intensa 744-PU
FDA UDI
Class IActive
Intensa 460-AA-PS-PU
FDA UDI
Class IActive
Everest & Jennings 90763541
FDA UDI
Class IActive
Intensa IN587WD1319PA
FDA UDI
Class IActive
Lumex FR587WDH1304PA
FDA UDI
Class IActive
Hausted 4600-AA-DW-OG
FDA UDI
Class IActive
Intensa 460-FS-AA-ST
FDA UDI
Class IActive
Everest & Jennings EJ786-1
FDA UDI
Class IActive
Lumex FR601PH6727
FDA UDI
Class IActive
Intensa 460-T4
FDA UDI
Class IActive
Intensa IN587WDBTPA
FDA UDI
Class IActive
Intensa IN577RG1304PA
FDA UDI
Class IActive
Intensa IN587WH9208PA
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.