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

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EASYPOINT NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

Freedom Pedicle Screw System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027698·

CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S

FDA 510(k)
FDA Class 2 ·Anesthesiology

MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

CORNERSTONE-SR TI-COATED CAGE SYSTEM

FDA Adverse Event
Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018

EONC

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·May 20, 2013

EON MINI RECHARGEABLE IPG

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 16, 2011

GE OEC 7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·August 20, 2008

LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

FDA Adverse Event
Malfunction ·COOK INC·Product code LJS·August 24, 2016

CORNERSTONE-SR TI-COATED CAGE SYSTEM

FDA Adverse Event
Malfunction ·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

GMK PRIMARY TOTAL KNEE SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 26, 2026

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 9, 2022

FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 12, 2018

CORNERSTONE-SR® TI-COATED CAGE SYSTEM

FDA Adverse Event
Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025

CORNERSTONE-SR® TI-COATED CAGE SYSTEM

FDA Adverse Event
Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 8, 2024

GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2019

GMK SPHERE FEMORAL COMPONENT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2017