7 results
·
16ms
·
Sources: EU EUDAMED, US FDA
VON WILLEBRAND FACTOR ASSAY
FDA 510(k)
FDA Class 2
·Hematology
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
FDA 510(k)
FDA Class 2
·Cardiovascular
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 9, 2014
IDRT-TS (INTL) SINGLE 4X5
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORP.·Product code MGR·October 19, 2012
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 11, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022