175 results · 20ms · Sources: EU EUDAMED, 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