7 results
·
24ms
·
Sources: EU EUDAMED, US FDA
LIMB HOLDER ARM SLING
FDA 510(k)
FDA Class 1
·Physical Medicine
VIEW 1 IMAGING
FDA 510(k)
FDA Class 2
·Radiology
VANGUARD REPROCESSED INFLATION DEVICES
FDA 510(k)
FDA Class 2
·Cardiovascular
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 16, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
QUILL SRS
FDA Adverse Event
Malfunction
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·August 13, 2010
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·April 4, 2018