Atlas FDA

NDS

9 FDA 510(k) clearances · Product code

164 daysmedian time to decision
447 days90th percentile
9clearances measured

FDA profile

Official device name
Media, Culture, Ex Vivo, Tissue And Cell
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5885
Medical specialty
Gastroenterology, Urology
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RecordFirmDate
MSC SFM (K232543)Yocon Biology Technology Company2024-09-06
“MoFi” Cell Culture Basal Medium (K240247)Duogenic Stemcells Corporation2024-07-12
PRIME-XV FreezIS DMSO-Free MD (K231804)Fujifilm Irvine Scientific2023-11-09
CT-STOR (K201789)Energy Delivery Solutions2021-09-20
OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM (K113566)Life Technologies, Inc.2012-06-21
STEMPRO MSC SFM (K103302)Life Technologies Corporation2011-02-18
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 (K100616)Life Technologies Corporation2010-05-20
AIM-V (R) MEDIUM, MODEL 087-0112 (K022086)Invitrogen Corporation2002-12-23
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) (DEN000008)Life Technologies, Inc.2001-02-16

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Every clearance here is in the API, with alerts when new ones post.