FLD · Class II · 21 CFR 876.5870

FDA Product Code FLD: Apparatus, Hemoperfusion, Sorbent

Leading manufacturers include Extracorporeal Medical Specialities, Inc. and Gambro, Inc..

11
Total
11
Cleared
208d
Avg days
1983
Since

FDA 510(k) Cleared Apparatus, Hemoperfusion, Sorbent Devices (Product Code FLD)

11 devices
1–11 of 11
Cleared Dec 29, 1987
GAMBRO ADSORBA 150C
K873643
Gambro, Inc.
Gastroenterology & Urology · 111d
Cleared May 30, 1984
HEMOPERFUSION SYSTEM TP-400
K840532
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 119d
Cleared Aug 26, 1983
HEMOPERFUSION SYSTEM TP-400
K831029
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 149d

About Product Code FLD - Regulatory Context