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

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EXCELSIOR

FDA 510(k)
FDA Class 2 ·Radiology

EVONOS

FDA UDI
Gyrus ACMI, LLC·00821925012318·MCGEE ROLLER KNIFE SAGITTAL 3.3 MM BLADE DIAMET...

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450407172·

RELIANCE ENDOSCOPE PROCESSING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

COOLTOUCH ND: YAG LASER SYSTEM

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

LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

ASR ACETABULAR IMPLANT 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·May 24, 2013

SENSIA DR

FDA Adverse Event
Malfunction ·MEDTRONIC S.A.·Product code NVZ·June 16, 2011

POWERLINK SYSTEM

FDA Adverse Event
Injury ·ENDOLOGIX, INC.·Product code MIH·August 19, 2008

INSPIRE 6F

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025

RESERVOIR INSPIRE 8

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026

LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018

INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

FDA Adverse Event
Injury ·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025

INSPIRE HARD VENOUS RESERVOIR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022

INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

FDA Adverse Event
Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·January 13, 2023

INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

FDA Adverse Event
SORIN GROUP ITALIA S.R.L.·Product code DTZ·December 19, 2016

INSPIRE HVR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·July 21, 2022

INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 5, 2019

INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY

FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTZ·October 5, 2016

INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOT

FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTZ·November 4, 2016