510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NDSClass II

Media, Culture, Ex Vivo, Tissue And Cell

21 CFR 876.5885 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NDS is the FDA product code for Media, Culture, Ex Vivo, Tissue And Cell, a class II device type, regulated under 21 CFR 876.5885. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
NDS
Device name
Media, Culture, Ex Vivo, Tissue And Cell
Regulation
21 CFR 876.5885
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
9
Ingested recalls
7

Clearances, product code NDS

By decision year
9 clearances under product code NDS with a decision year between 2001 and 2024, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NDS by decision year
YearClearances
20011
20021
20101
20111
20121
20211
20231
20242

Applicants with the most clearances

Product code NDS
Applicants holding the most 510(k) clearances under product code NDS
ApplicantClearances
Life Technologies Corporation4
Duogenic Stemcells Corporation1
Energy Delivery Solutions1
FUJIFILM Biosciences Inc.1
Invitrogen Corporation1
Yocon Biology Technology Company1

Companies listing this code with FDA

Companies whose registered establishments list this code