22 results
·
19ms
·
Sources: EU EUDAMED, US FDA
SUTURE FIXATION DEVICE; MESH FIXATION DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310218343·FG Diamond 879K-016 curettage coarse 5/pack
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
BIS ENGINE
FDA 510(k)
FDA Class 2
·Neurology
PROFILE DRILL, MINI CMP FT
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code NBH·December 23, 2025
LUMAX 740 VR-T PROMRI
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·March 26, 2013
CHROMIC GUT
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAL·March 9, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·March 28, 2008
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
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018