7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SYSTEM, PLANNING, TREATMENT
FDA 510(k)
FDA Class 2
·Radiology
TruDi NAV Suction Instruments
FDA 510(k)
FDA Class 2
·Neurology
HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COULTER® ACT DIFF[ ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·April 30, 2014
ACCU-CHEK PERFORMA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 10, 2012
EXCALIBUR WALKER
FDA Adverse Event
Injury
·PINGHU ASPEL TECHNOLOGY CORP.·Product code ITJ·July 29, 2010
Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016