22 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VERTEX RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·December 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·May 7, 2009
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC·Product code KWP·August 11, 2009
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·March 19, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·August 2, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 1, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·August 6, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·December 22, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·December 22, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWQ·November 2, 2009
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·December 11, 2017
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·December 28, 2010
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 25, 2014
DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)
FDA 510(k)
FDA Class 2
·Dental
DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
GRAFTYS HBS (510K NUMBER: K082498)
FDA Adverse Event
Injury
·GRAFTYS·Product code MQV·July 11, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 20, 2025
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 3, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 6, 2011