8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
PHADEBACT SHIGELLA TEST
FDA 510(k)
FDA Class 2
·Microbiology
CONCEIVEX LATEX-FREE SEMEN COLLECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 6, 2024
2.5FR URETHANE UMB CATH
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FOS·May 29, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·October 25, 2010
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·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