35 results · 23ms · 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.

INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir

FDA 510(k)
FDA Class 2 ·Cardiovascular

INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 14, 2019

INSPIRE 7M HOLLOW FIBER OXYGENATOR, INSPIRE 7 DUAL HOLLOW FIBER OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·June 19, 2019

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319741726·Spinal Fusion Curette 7-3/4" (20cm), reverse an...

VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING

FDA 510(k)
FDA Class 2 ·Cardiovascular

ONE PERSONAL LUBRICANT (SILICONE)

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 5, 2025

BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·April 14, 2023

PD1400 DEFIBRILLATOR/PACEMAKER

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code LDD·October 3, 2008

SITTER II

FDA Adverse Event
Malfunction ·J. T. POSEY CO.·Product code KMI·July 29, 2011

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON MANUFACTURING, LTD.·Product code HQC·June 21, 2013

STEM: M-VIZION 01.22.102 DISTAL STEM 13MM L 140MM STRAIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 1, 2021

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 2, 2025

REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code KFM·December 11, 2025

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 21, 2024

M-VIZION PROXIMAL BODY Ø20MM L 70MM LAT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 22, 2024

REVOLUTION CENTRIFUGAL BLOOD PUMP COATED

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code KFM·November 11, 2024

REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·December 2, 2022

MPACT ACETABULAR SHELL Ø54 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 20, 2023

REVOLUTION PHISIO CENTRIFUGAL PUMP

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·June 23, 2021