175 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MiRus Lumbar Interbody Fusion System consisting of CALLISTO PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES PEEK Anterior Lumbar Interbody Fusion (ALIF)
FDA 510(k)
FDA Class 2
·Orthopedic
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704513493·
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100974·DESMARRES LID RETRACTOR #2
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180538760·SQUARE ENDPLATE SCRAPER, DOWN ANGLED
ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
RANGE SPINAL SYSTEM (MESA AND DENALI)
FDA 510(k)
FDA Class 2
·Orthopedic
SURDIAL X
FDA Adverse Event
Malfunction
·SHIBUYA (SBY)·Product code KDI·August 5, 2021
SURDIAL X
FDA Adverse Event
Malfunction
·SHIBUYA (SBY)·Product code KDI·August 5, 2021
SURDIAL X
FDA Adverse Event
Malfunction
·SHIBUYA (SBY)·Product code KDI·August 5, 2021
SURDIAL X
FDA Adverse Event
Malfunction
·SHIBUYA (SBY)·Product code KDI·August 5, 2021
SURDIAL X
FDA Adverse Event
Malfunction
·SHIBUYA (SBY)·Product code KDI·August 5, 2021
SURDIAL X
FDA Adverse Event
Malfunction
·SHIBUYA (SBY)·Product code KDI·August 5, 2021
SURDIAL X
FDA Adverse Event
Malfunction
·SHIBUYA (SBY)·Product code KDI·August 5, 2021
SURDIAL X
FDA Adverse Event
Malfunction
·SHIBUYA (SBY)·Product code KDI·August 5, 2021
SURDIAL X
FDA Adverse Event
Malfunction
·SHIBUYA (SBY)·Product code KDI·August 5, 2021
SURDIAL X
FDA Adverse Event
Malfunction
·SHIBUYA (SBY)·Product code KDI·August 5, 2021
NIPRO BLOOD TUBING SET W/TP
FDA Adverse Event
Malfunction
·NIPRO (THAILAND) CORP. LTD.·Product code FJK·February 6, 2024
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·September 1, 2022
SURDIAL X
FDA Adverse Event
Malfunction
·SHIBUYA (SBY)·Product code KDI·August 5, 2021
ZILVER 635 SELF-EXPANDING BILIARY STENT
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FGE·August 29, 2022