11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
PH ELECTRODE CALIBRATING BUFFERS-BLOOD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)
FDA 510(k)
FDA Class 2
·Orthopedic
FERRITIN RIA KIT
FDA 510(k)
FDA Class 2
·Immunology
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 20, 2015
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 18, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 22, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·May 30, 2014
ASR XL TAP SLV ADAP 12/14+5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 20, 2012
PATIENT ROOM WALL SAVER RECL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FRK·September 10, 2010
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 22, 2013
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015