23 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AART SILICONE CARVING BLOCK
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·April 14, 2022
DENTORIUM CONVERTIBLE ACRYLIC
FDA 510(k)
FDA Class 2
·Dental
AIA-PACK CTNI 2ND-GEN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·April 14, 2022
ACTIVE ARTICULATION E1 28MM ID X 50MM OD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·March 26, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 17, 2011
ELLIPSE DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·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
CANNULA & CATHETER
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DWF·April 22, 2025
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