22 results · 23ms · Sources: EU EUDAMED, US FDA

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ExcelsiusGPS

FDA 510(k)
FDA Class 2 ·Neurology

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804854·Baron Suction Tube, 3fr

Pre-Finisher

FDA UDI
TP ORTHODONTICS INC·00192029042519·Asian 4 Bicuspid Extraction

POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD

FDA 510(k)
FDA Class 2 ·Dental

VAPR 3.5MM SUCTION ELECTRODE

FDA Adverse Event
Malfunction ·DEPUY MITEK·Product code GEI·October 6, 2008

L9000 LIGHTSOURCE

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code GCT·July 27, 2011

POWER LOAD

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 26, 2013

REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code KFM·December 11, 2025

REVOLUTION CENTRIFUGAL BLOOD PUMP COATED

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code KFM·November 11, 2024

REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·December 2, 2022

REVOLUTION PHISIO CENTRIFUGAL PUMP

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·June 23, 2021

REVOLUTION PHISIO CENTRIFUGAL PUMP

FDA Adverse Event
Injury ·SORIN GROUP ITALIA SRL·Product code KFM·May 20, 2021

CENTRIFUGAL PUMP REVOLUTION 5

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code KFM·August 3, 2023

CENTRIFUGAL PUMP REVOLUTION 5

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code KFM·August 3, 2023

AVAN REINF RING SS 48/58MM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·December 29, 2025

REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·September 14, 2022

REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·March 17, 2023

REVOLUTION CENTRIFUGAL BLOOD PUMP COATED

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·June 19, 2025

BD MAX¿ CPO

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025