41 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.

VIPER SYSTEMS

FDA 510(k)
FDA Class 2 ·Orthopedic

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213036284·Coupling Treatment Tube for 6F Flexibles (24)

XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS

FDA 510(k)
FDA Class 2 ·Cardiovascular

TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE

FDA 510(k)
FDA Class 2 ·Anesthesiology

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 13, 2023

OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

FDA Enforcement
Class II ·Terminated·Oscor, Inc.·December 28, 2016

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·May 6, 2013

STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·September 23, 2014

UNKNOWN DEPUY REPLICA STEM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·May 13, 2011

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 13, 2021

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020

GMK SPHERE TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 18, 2025

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2020

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 27, 2019

Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96, REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Reps, Inc., Tinley Park, Illinois

FDA Enforcement
Class II ·Terminated·Ecolab Inc·February 19, 2014

BD IV SYRINGES 5 ML

FDA Adverse Event
Other ·BD·Product code FMF·September 2, 2016

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 7 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 28, 2022

GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 LEFT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 24, 2017

GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 11, 2020