8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MCGHAN INTEGRAL VALVE TISSUE EXPANDER
FDA 510(k)
FDA Unclassified
·Unknown
DePuy Synthes
FDA UDI
Tecomet·00817766025488·Thoracolumbar Instruments 2 Stainless Steel
PATIENT MONITOR MODEL RM-300
FDA 510(k)
FDA Class 2
·Cardiovascular
LEPTOS PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·June 6, 2014
VIRTUOSO VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 5, 2010
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NEK·November 27, 2012
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024