23 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO BLUE SKY DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MB 103 MILLENNIUM BLADES
FDA 510(k)
FDA Class 1
·Ophthalmic
PREFERENCE TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
TRILOGY SHELL
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·September 11, 2020
LINOX SMART S DX 65/17
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·March 26, 2013
TERUMO VIRTUOSAPH PLUS VEIN HARVESTING SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·February 25, 2011
ACCU-CHEK TENDER INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FOZ·March 28, 2008
FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·May 29, 2019
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
REFLECTION CONSTRAINED ACETABULAR LINER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KWZ·June 8, 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