17 results · 23ms · Sources: EU EUDAMED, US FDA

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SLEEK OTW PTA CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SLEEK OTW PTA CATHETER

FDA Adverse Event
Injury ·CLEARSTREAM TECHNOLOGIES LTD.·Product code DQY·December 13, 2023

LINK Instruments - Chisel, bone curette, raspatory, rongeur

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575234066·Orthopaedic prosthesis instrument, reusable - G...

LINK Instruments - Chisel, bone curette, raspatory, rongeur

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575234059·Orthopaedic prosthesis instrument, reusable - G...

MONO-SWIFT

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CUSA EXCEL 23KHZ STANDARDTIP

FDA Adverse Event
Malfunction ·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·December 22, 2015

MULTI-LINK VISION CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code MAF·May 24, 2013

QUADRA ASSURA DR CRT-D, DF-4 CONNECTOR

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

ATTAIN ABILITY

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·July 26, 2024

ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·October 6, 2022

UNKNOWN

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·July 15, 2020

ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·February 9, 2023

ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

FDA Adverse Event
Malfunction ·COOK INC·Product code DQX·December 6, 2024

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

FDA Enforcement
Class II ·Terminated·Senseonics, Inc.·November 6, 2019

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012