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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

SYLE SMARTIP

FDA 510(k)
FDA Class 1 ·Dental

DEPUY ACROMED VBR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PTN

FDA Adverse Event
Injury ·EBI, LLC·Product code HSB·October 28, 2009

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OYC·May 24, 2013

DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·September 30, 2014

ADVISA DR

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

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

MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS

FDA Adverse Event
Malfunction ·MENTOR TEXAS·Product code LCJ·October 20, 2020

MENTOR CPX 4 BREAST TISSUE EXPANDER

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·May 24, 2022

INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

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

MENTOR CPX 4 BREAST TISSUE EXPANDER

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·June 27, 2024

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