8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EMIT THYROXINE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Archon
FDA UDI
Nuvasive, Inc.·00887517305305·Archon Screw, 4.5x20mm S.T. Var Recon
MODIFICATION TO 3M TEGADERM CHG DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
Endophys Pressure Sensing Sheath Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 19, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 30, 2015
Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025