9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
AIRCAST TENNIS ARM BAND
FDA 510(k)
FDA Class 1
·Physical Medicine
NTERFACE
FDA UDI
WINFIELD LABORATORIES INC·00858150000490·Large Sheet 12 inches X 24 inches - Box 12
ANEUVYSION MULITICOLOR DNA PROBE KIT
FDA 510(k)
FDA Class 2
·Immunology
FEMVUE SALINE-AIR DEVICE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
AMISTEM-P
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 4, 2025
LCS COMP RP INSERT LG 10MM
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, DIV. OF DEPUY ORTHOPAEDICS 1219655·Product code NJL·May 14, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 31, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·August 20, 2010
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017