11 results
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18ms
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Sources: EU EUDAMED, US FDA
WAKO(TM) AUTOKIT LIPASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Medtronic Resuable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000679538·PLATE HOLDER 9874640 4 HOLE
Medtronic Resuable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994285096·PLATE HOLDER 9874640 4 HOLE
Cystotome
FDA UDI
KATENA PRODUCTS, INC.·00841668113172·CYSTOTOME DOUBLE EDGE SMALL
MODIFIED CORONARY CARDIOPLEGIA ADAPTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
POLYSTAT, BIOLOGICAL STAIN
FDA 510(k)
FDA Class 1
·Hematology
TDX/TDXFLX CANNABINOIDS REAGENT
FDA Adverse Event
Injury
·ABBOTT HEALTH PRODUCTS, INC.·Product code LDJ·November 8, 2006
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code MBI·June 16, 2014
KAPPA 700 DR
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code DXY·October 19, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·December 15, 2012
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