7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
OPART, MODEL MRT-600
FDA 510(k)
FDA Class 2
·Radiology
SERUM 11-DESOXYCORTISOL I AS TRACER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DORO LUCENT® iXI and iMRI Headrest System
FDA 510(k)
FDA Class 2
·Neurology
CONSERVE(R) SUPER FINISH FEMORAL
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KXA·March 6, 2013
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
CAPSURE SP
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·August 8, 2014
Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·May 16, 2018