8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CALCIUM REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Conceive Plus
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008457·Fertility Lubricant
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Maxima Electric System
FDA 510(k)
FDA Class 1
·Dental
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·April 9, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code FSA·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