7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO
FDA 510(k)
FDA Class 2
·Orthopedic
MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT
FDA 510(k)
FDA Class 2
·Cardiovascular
PRIMADERM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
7.0MM TI SIDE-OPENING SCREW 50MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·June 16, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 19, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 15, 2012
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020