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

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SOLUTIS

FDA 510(k)
FDA Class 2 ·Ophthalmic

PASCO MIC AND MIC/ID PANELS

FDA 510(k)
FDA Class 2 ·Microbiology

CONSENSUS CS2 PLUS ACETABULAR INSERT

FDA 510(k)
FDA Class 2 ·Orthopedic

INSERTER-LARGE

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code MCV·May 24, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

WALLSTENT RX BILIARY ENDOPROSTHESIS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code FGE·August 21, 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

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

INSPIRE 6M HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER HARDSHELL VEN/CARD RES

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 6, 2016

INSPIRE 8F HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VEN/CARDIOTOMY RESERV

FDA Adverse Event
Malfunction ·SORIN GROUP ITALI SRL·Product code DTZ·October 20, 2016

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

FDA Adverse Event
SORIN GROUP ITALIA SRL·Product code DTZ·October 6, 2016

INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 26, 2017