12 results
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25ms
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Sources: EU EUDAMED, US FDA
DOPPLEX-PLB & PXB
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517366801·CoRoent® Small, 10x11x14mm
DD Bio Splint P
FDA UDI
Dental Direkt GmbH·EDDIK101151·DD Bio Splint P are transparent dental milling ...
Needle Holder
FDA UDI
KOROS U.S.A., INC.·10840199534132·Needle Holder Micro Tungsten Grip Straight Stai...
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101150·Distractor, Smooth Paddle, Lordotic, 15mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101150·Distractor, Smooth Paddle, 15mm
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TWBM Pump
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014
COBALT HV BONE CEMENT
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LOD·October 31, 2012
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·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