22 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074034713·BONE SCREW 7021880 10 DEG ILC 8.5X80 SS
COMPEX SPORT
FDA 510(k)
FDA Class 2
·Physical Medicine
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AUTO ENDO5 ML
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·August 8, 2017
MULTI-LINK CORONARY STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code MAF·March 26, 2013
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 25, 2011
LANCET DEVICE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·August 19, 2014
SORIN BIOMEDICA SMARXT BCD VANGUARD
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·November 20, 2019
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·November 16, 2016
MUSC CHARLESTON SC 1
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DWF·March 28, 2012
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTR·October 28, 2016
SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·April 27, 2023
SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·December 15, 2023
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·November 2, 2016
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTR·October 28, 2016
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTR·October 28, 2016
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·February 3, 2021
SORIN BIOMEDICA SMARXT BCD VANGUARD
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTR·November 20, 2019
ONYX
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·August 12, 2025