15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides
FDA 510(k)
FDA Class 2
·Orthopedic
ZEUS-O
FDA UDI
SPINAL ELEMENTS·00840916122485·Zeus-O Implant, 15 x 09 x 28mm
Oticon
FDA UDI
Oticon A/S·05707131284150·RIA2 PRO TI, BTE 13 WL 85 CNB
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P1509280·15mm PLIF Implant 9mm Wide 28mm Length
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587P15092870·15mm PLIF Implant 9mm Wide 28mm Length 7 Degrees
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869607636·TELIX K Ti Cage 9x28mm 5
MICRO DIARY SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
DADE THROMBIN REAGENT
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
UNIVERSAL NAVLOCK INSTRUMENT SET
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code OLO·June 23, 2016
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KXA·June 6, 2013
HIP HEAD, 10/12 TAPER, 28MM, +0MM
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWY·June 29, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 3, 2008
VA LOCKSCR Ø2.4 SELF-TAP L18 TAN
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HRS·August 18, 2017
UNIVERSAL NAVLOCK INSTRUMENT SET
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code OLO·June 23, 2016