9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MALLEOLAR SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471129450·K-WIRE - DOUBLE TROCAR WITH GUIDE 1.6mm DIA x 1...
INOMAX DSIR (DELIVERY SYSTEM)
FDA 510(k)
FDA Class 2
·Anesthesiology
AEROMIST LT, MODEL HCS15004
FDA 510(k)
FDA Class 2
·Anesthesiology
DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DWF·December 15, 2016
TOTAL ASR FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·January 28, 2013
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·November 22, 2010
SIGMA PS CEM FEM SZ4 R
FDA Adverse Event
Injury
·DEPUY IRELAND ¿ REG. # 9616671·Product code JWH·July 14, 2014
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014