8 results
·
33ms
·
Sources: EU EUDAMED, US FDA
MECHANICAL ADJUSTABLE CHAIR (AC POWERED)
FDA 510(k)
FDA Class 2
·Physical Medicine
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·June 23, 2016
Vinyl Examination Glove (Clear, Non-Colored)
FDA 510(k)
FDA Class 1
·General Hospital
MICRUS ASCENT OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·April 9, 2014
100% SILICONE 2WAY 30CC FOLEY CATHETER 18 FR
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code KOD·October 1, 2010
LOCKING SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 20, 2012
Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025