50 results
·
34ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NewTom 5G XL
FDA 510(k)
FDA Class 2
·Radiology
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271173·
Vanguard Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304465947·
BRIVO XR385
FDA 510(k)
FDA Class 2
·Radiology
CABLE, TRANSDUCER, MODEL 2400GN
FDA 510(k)
FDA Class 2
·Cardiovascular
VANGUARD DCM CR TIBIAL BEARING
FDA Adverse Event
Malfunction
·BIOMET, INC.·Product code JWH·May 20, 2008
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2020
INSPIRE 8F M
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·January 3, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
SYNCHRON® LX20 PRO ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·July 28, 2011
ARCOM SERIES A STANDARD PATELLA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·June 20, 2018
INSPIRE 8F M
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·January 4, 2024
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026
INSPIRE OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026
Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448.
FDA Recall
Terminated
·Biomet, Inc.·Product code JWH·February 12, 2008
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025
INSPIRE 8F
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025
INSPIRE OXYGENATOR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·December 11, 2025
INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 20, 2021