7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
OHIO CARE PLUS INCUBATOR
FDA 510(k)
FDA Class 2
·General Hospital
MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR
FDA 510(k)
FDA Class 2
·Orthopedic
VITROS 5600 INTEGRATED SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·February 5, 2013
PRESERVCYT
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code MKQ·December 23, 2010
LOCKING HOLDING SLEEVE-LONG FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·July 18, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021