7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
FDA 510(k)
FDA Class 3
·Orthopedic
nva, nvp, and nvt
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·December 10, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 23, 2015
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