FLD · Class II · 21 CFR 876.5870

FDA Product Code FLD: Apparatus, Hemoperfusion, Sorbent

Leading manufacturers include Hemocleanse, Inc., Gambro Renal Products, Inc. and Extracorporeal Medical Specialities, 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 Mar 26, 2014
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT
K133807
Gambro Renal Products, Inc.
Gastroenterology & Urology · 100d
Cleared Dec 14, 2012
MOLECULAR ADSORBENT RECIRCULATING(MARS)
K113313
Gambro Renal Products, Inc.
Gastroenterology & Urology · 401d
Cleared May 27, 2005
MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
K033262
Gambro Renal Products
Gastroenterology & Urology · 596d
Cleared Sep 10, 1999
BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
K992196
Hemocleanse, Inc.
Gastroenterology & Urology · 72d
Cleared Aug 13, 1999
BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
K984546
Hemocleanse, Inc.
Gastroenterology & Urology · 234d
Cleared Oct 22, 1997
AHCS HEMOPERFUSION SYSTEM
K971015
American Health Care Systems, Inc.
Gastroenterology & Urology · 216d
Cleared Feb 15, 1996
BIOLOGIC-DT SYSTEM
K953751
Hemocleanse, Inc.
Gastroenterology & Urology · 189d
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