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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 83 of 91
DeviceModel / ReferenceRegistriesClassStatus
Everest & Jennings 90763431
FDA UDI
Class IUnknown
Intensa 620-DA-T5
FDA UDI
Class IActive
Intensa IN587WD1325
FDA UDI
Class IActive
Basic American Medical Products MM7114
FDA UDI
Class IIActive
Intensa IN566DGH1319PA
FDA UDI
Class IActive
Intensa 460-AA-DO
FDA UDI
Class IActive
Labtron 510GY
FDA UDI
Class IActive
Everest & Jennings 90763054A
FDA UDI
Class IActive
John Bunn JB02017
FDA UDI
Class IIActive
Transfer Master B407-Q-C
FDA UDI
Class IIActive
Intensa 460-FS-PS-SH
FDA UDI
Class IActive
Basic American Medical Products Z7ASW
FDA UDI
Class IIActive
Everest & Jennings 90-011B1J
FDA UDI
Class IActive
Intensa IN587WHPL
FDA UDI
Class IActive
Intensa IN566GH6714
FDA UDI
Class IActive
Intensa 744B-T8
FDA UDI
Class IActive
Intensa IN601UHPM
FDA UDI
Class IActive
Everest & Jennings 3G010450
FDA UDI
Class IActive
Intensa IN566DGHNAPA
FDA UDI
Class IActive
Intensa IN587WDBPA
FDA UDI
Class IActive
Intensa IN577RGHDO
FDA UDI
Class IActive
Intensa 460-AA-PS-AR
FDA UDI
Class IActive
Intensa IN587WH6725
FDA UDI
Class IActive
Intensa 460-FS-DW-T6
FDA UDI
Class IActive
Intensa 620-DA-PL
FDA UDI
Class IActive
LabTron V223
FDA UDI
Class IIActive
Intensa 460-DW-AR
FDA UDI
Class IActive
Intensa 460-DW-T9
FDA UDI
Class IActive
Intensa 744CB-AL
FDA UDI
Class IActive
Lumiscope 100-021
FDA UDI
Class IIActive
Intensa IN597P8604
FDA UDI
Class IActive
Intensa IN587WD6725
FDA UDI
Class IActive
Intensa IN587WDHPLPA
FDA UDI
Class IActive
Intensa 420-WG
FDA UDI
Class IActive
Intensa IN587WH9210
FDA UDI
Class IActive
Intensa 460-PU
FDA UDI
Class IActive
Intensa 748CB-NA
FDA UDI
Class IActive
Grafco 4109-1
FDA UDI
Class IActive
Intensa 748B-OG
FDA UDI
Class IActive
Intensa IN587WDH9210
FDA UDI
Class IActive
LabTron 203
FDA UDI
Class IIActive
Intensa 748CB-DB
FDA UDI
Class IActive
Everest & Jennings 3F020150
FDA UDI
Class IActive
Everest & Jennings EJ78-SLEEVEA
FDA UDI
Class IActive
Intensa IN587WDHAR
FDA UDI
Class IActive
Intensa IN587WD6714PA
FDA UDI
Class IActive
Intensa IN587WHWW
FDA UDI
Class IActive
Intensa IN597G409
FDA UDI
Class IActive
Everest & Jennings 90763542
FDA UDI
Class IActive
Intensa IN597P8516
FDA UDI
Class IActive

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Authorised Representatives

No authorised representatives on record.

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.