7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
TRACK AND CARRIER, INTRAVENOUS
FDA 510(k)
FDA Class 1
·General Hospital
IDEAL LIFE POD (MODEL ILP 0001)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
gammaCore Sapphire
FDA 510(k)
FDA Class 2
·Neurology
DELTA HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code LZO·October 20, 2010
ATLAS PLUS HF CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·December 19, 2012
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