7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
HC PLUS
FDA 510(k)
FDA Class 2
·Hematology
SMARTSET GHV GENTAMICIN BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
PATHASSIST LIGHT SEEKER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 15, 2012
M2A-MAGNUM MOD HD SZ 44MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 27, 2014
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2015
Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC
FDA Enforcement
Class II
·Terminated·Cook Inc.·January 22, 2020