510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
FLDClass II

Apparatus, Hemoperfusion, Sorbent

21 CFR 876.5870 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FLD is the FDA product code for Apparatus, Hemoperfusion, Sorbent, a class II device type, regulated under 21 CFR 876.5870. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
FLD
Device name
Apparatus, Hemoperfusion, Sorbent
Regulation
21 CFR 876.5870
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
7

Clearances, product code FLD

By decision year
11 clearances under product code FLD with a decision year between 1983 and 2014, 1999 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FLD by decision year
YearClearances
19831
19841
19871
19891
19961
19971
19992
20051
20121
20141

Applicants with the most clearances

Product code FLD
Applicants holding the most 510(k) clearances under product code FLD
ApplicantClearances
Gambro Renal Products3
Hemocleanse, Inc.3
Extracorporeal Medical Specialities, Inc.2
American Health Care Systems, Inc.1
Asahi Kasei Medical MT Corp. Oita Works1
Gambro, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code