7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PERFECTA TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
FDA 510(k)
FDA Class 2
·Cardiovascular
Navi e/Navi s/Navi X Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
NOVA MAX GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORP.·Product code NBW·October 8, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
S-ROM M HEAD 36MM +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·December 19, 2012
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025