12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
RESPA-TROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101070·Distractor, Smooth Paddle, Lordotic, 7mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101070·Distractor, Smooth Paddle, 7mm
TheRay Collared and Collarless Femoral Stem
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127026447·NECK TRIAL, COLLARED STEM, LATERAL, SIZE 7
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127020230·Neck Trial, Size 7, Standard
R STENT BILIARY ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Blue Sky Bio Aligner
FDA 510(k)
FDA Class 2
·Dental
CONNECTOR LUER LOCK C45J
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code LHI·September 11, 2019
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·April 10, 2014
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·October 31, 2012
NI
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code NKB·August 17, 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