25 results · 31ms · 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.

LEGION System

FDA 510(k)
FDA Class 2 ·Ophthalmic

CD HORIZON® Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074465296·CDH HA COATED MAS 6.5X50

Sklar®

FDA UDI
SKLAR CORPORATION·10649111202285·TISSUE FCP 3X4 5"

AXS-590 SERIES

FDA 510(k)
FDA Class 2 ·Anesthesiology

IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·December 3, 2010

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 20, 2011

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 26, 2013

REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)

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

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

REVOLUTION PHISIO CENTRIFUGAL PUMP

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

REVOLUTION PHISIO CENTRIFUGAL PUMP

FDA Adverse Event
Injury ·SORIN GROUP ITALIA SRL·Product code KFM·May 20, 2021

CENTRIFUGAL PUMP REVOLUTION 5

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code KFM·August 3, 2023

CENTRIFUGAL PUMP REVOLUTION 5

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code KFM·August 3, 2023

REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·September 14, 2022

REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·March 17, 2023

REVOLUTION CENTRIFUGAL BLOOD PUMP COATED

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code KFM·June 19, 2025