17 results · 22ms · Sources: EU EUDAMED, US FDA

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iFUSE Implant System

FDA 510(k)
FDA Class 2 ·Orthopedic

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017866·K-Wire, Double Ended, Trocar Point, Diameter Si...

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017873·K-Wire, Double Ended, Trocar Point, Diameter 0....

ACL TIGHTROPE

FDA 510(k)
FDA Class 2 ·Orthopedic

TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

CONTOUR NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 22, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

CAPSURE SENSE

FDA Adverse Event
Injury ·MPRI·Product code DTB·October 10, 2014

MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 10, 2013

GOBED II MED/SURG BED

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·June 30, 2011

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FDA Adverse Event
Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021

CONTOUR NEXT (CONNECTED)

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 2, 2021

Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

FDA Enforcement
Class II ·Terminated·Synthes, Inc.·July 22, 2015