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

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I-MAX TOUCH 3D

FDA 510(k)
FDA Class 2 ·Radiology

Gyrus ACMI

FDA UDI
Gyrus ACMI, LLC·00821925018525·MCGEE DOUBLE-BLADED KNIFE

Marienfeld Superior

FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317358196·

MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST

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

DEFINITIVE, FLEXLENS - SILICONE HYDROGEL

FDA 510(k)
FDA Class 2 ·Ophthalmic

SD/PD LONG CURVED

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·May 24, 2013

NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Injury ·COCHLEAR LTD.·Product code MCM·June 16, 2011

SYNERGY

FDA Adverse Event
Injury ·MDT PUERTO RICO OEPRATIONS CO, MED REL·Product code LGW·August 8, 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