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

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Stat Profile Prime Plus Analyzer System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Patella Clamp

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215064051·

MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY

FDA 510(k)
FDA Class 2 ·Cardiovascular

OLYMPUS EMPOWER H65

FDA Adverse Event
Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

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

OT ULTRAMINI ENHANCED METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·July 27, 2011

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 17, 2014

INSPIRE 8F M

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

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

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

INSPIRE 8F

FDA Adverse Event
Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·July 24, 2025