7 results
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25ms
·
Sources: EU EUDAMED, US FDA
HEP-2 CELLS
FDA 510(k)
FDA Class 1
·Hematology
DIAZYME LITHIUM ENZYMATIC ASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AERONEB SOLO; AERONEB SOLO ADAPTER
FDA 510(k)
FDA Class 2
·Anesthesiology
OBTAPE TRANSOBTURATOR SLING
FDA Adverse Event
Injury
·MENTOR WORLDWIDE LLC·Product code OTN·May 14, 2014
UNKNOWN DEPUY POLY LINER
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code KWA·November 15, 2012
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 13, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024