7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EXTRACORPOREAL SUBCLAVIAN CATHETER KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SI Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FOREMERLY NELLCO·Product code CBK·April 11, 2014
TI MIRS LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·December 14, 2012
PLASMABLADE 4.0 TISSUE DISSECTION DEVICE
FDA Adverse Event
PEAK SURGICAL, INC.·Product code GEI·September 28, 2010
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024