7 results
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19ms
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Sources: EU EUDAMED, US FDA
GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT
FDA 510(k)
FDA Class 1
·Microbiology
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
OSTAPEK VBR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·April 18, 2014
PROLITE MESH
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORPORATION·Product code FTL·December 11, 2012
ON-Q PAIN PUMP
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·September 8, 2010
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024