55 results · 24ms · Sources: EU EUDAMED, US FDA

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ARTLINE

FDA 510(k)
FDA Class 2 ·Cardiovascular

LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ASCENSION MODULAR TOTAL SHOULDER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PENUMBRA MAX PUMP - INDIGO SYSTEM

FDA Adverse Event
Malfunction ·PENUMBRA INC., USA·Product code NRY·August 23, 2018

INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2020

INSPIRE 8F M

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 3, 2024

PERMANENT CAUTERY SPATULA INSTRUMENT

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

SOFTCLIX ® LANCET DEVICE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 13, 2011

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FRN·September 16, 2008

INSPIRE 8F M

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·January 4, 2024

PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·March 8, 2018

INSPIRE OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026

INSPIRE OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 12, 2026

PENUMBRA SYSTEM ASPIRATION PUMP MAX 220

FDA Adverse Event
Malfunction ·PENUMBRA, INC.·Product code NRY·April 9, 2018

INSPIRE 8F

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025

INSPIRE 8F

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·November 5, 2025

INSPIRE OXYGENATOR

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·December 11, 2025

INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 20, 2021

INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 11, 2020

INSPIRE 8F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·December 23, 2020