Atlas FDA

LPZ

6 FDA 510(k) clearances · Product code

174 daysmedian time to decision
817 days90th percentile
6clearances measured

FDA profile

Official device name
Container, Frozen Donor Tissue Storage
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
1995: 1 · 2011: 5 · 2016: 16 · 2017: 24 · 2018: 23 · 2020: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CRYOBAG, MODEL CB (K021702)Origen Biomedical, Inc.2002-08-06
CRYOBAG (K915471)Janus Biomedical, Inc.1994-03-02
TAMPER HAMPER (K863872)Hydro-Med Products, Inc.1987-02-10
ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE (K861761)Travenol Laboratories, S.A.1986-08-28
AMPU-PAK (K860511)Ammerman Medical Enterprises, Inc.1986-08-04
ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR (K853663)Travenol Laboratories, S.A.1986-04-09

Track LPZ automatically

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