27 results · 26ms · Sources: EU EUDAMED, US FDA

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Kodiak Spinal Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

INVICTUS SPINAL FIXATION SYSTEM

FDA Adverse Event
Injury ·ALPHATEC SPINE, INC.·Product code NKB·April 30, 2025

INRATIO2 PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2016

SAVI APPLICATOR KIT

FDA 510(k)
FDA Class 2 ·Radiology

HOSPIRA INFUSION BLOOD SETS

FDA 510(k)
FDA Class 2 ·General Hospital

INRATIO2 PT/INR TEST STRIPS

FDA Adverse Event
Injury ·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2016

SOLUSET 100X60W/CAI

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 30, 2013

INRATIO PT/INR TEST STRIPS

FDA Adverse Event
Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·October 18, 2016

Y-SHAPED BLOOD SET W/ PUMP

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·September 12, 2013

Y-SHAPED BLOOD SET W/ PUMP

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code BRZ·September 13, 2013

SOLUSET 100X60W/CAI

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·August 6, 2013

SOLUSET 100X60W/CAI

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 17, 2013

NDEHP Y-BLOOD SET W/FILTER PUMP 203CM

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 24, 2011

SOLUSET 100X60W/CAI

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·August 6, 2013

SOLUSET 100X60W/CAI

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 10, 2013

M2A-MAGNUM MOD HD SZ 48MM

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 21, 2013

MINI-CAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 27, 2011

GORE TAG THORACIC ENDOPROSTHESIS

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES·Product code MIH·September 30, 2008

SOLUSET 100X60

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·October 22, 2013

SOLUSET 100X60

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·October 22, 2013