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SINGLE USE STENT INSERTION KIT V

FDA Adverse Event
Malfunction ·AOMORI OLYMPUS CO., LTD.·Product code QGE·May 4, 2026

THERMOCOOL SMARTTOUCH

FDA Adverse Event
Injury ·BIOSENSE WEBSTER INC·Product code LPB·October 8, 2025

UNKNOWN METAL SUTURE ANCHOR

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JDR·November 4, 2022

Biliary Stent, Drain, And Dilator Accessories

FDA classification
FDA Class 1 ·Biliary Stent, Drain, And Dilator Accessories

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

FDA Enforcement
Class II ·Ongoing·GE Healthcare, LLC·August 31, 2022

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

FDA Recall
Open, Classified ·GE Healthcare, LLC·Product code LLZ·July 15, 2022

GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system

FDA Recall
Terminated ·Product code RCE·January 13, 2015

GE Inspection Technologies x|argos 160D system. Cabinet x-ray system.

FDA Recall
Terminated ·Product code RCE·January 13, 2015

MADA MEDICAL PRODUCTS, INC.

FDA UDI
MADA MEDICAL PRODUCTS, INC·00815160020832·A device that is connected to an independent su...

CableAGE

FDA UDI
CAMBRIDGE INTERVENTIONAL LLC·00811746030783·Cable Adapter

C6-2GE Ultrasonic Transducer(FDA)

FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088310·

AGEE EXTERNAL FIXATOR

FDA 510(k)
FDA Class 2 ·Orthopedic

BAND-AGE ICE-BANDAGE

FDA 510(k)
FDA Class 2 ·Physical Medicine

Butterfly Gestational Age Tool

FDA 510(k)
FDA Class 2 ·Radiology

AGEE-WRISTJACK PRE-DRILL KIT

FDA 510(k)
FDA Class 1 ·Orthopedic

LIGHT AGE EPICARE ALEXANDRITE LASER

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

Neutrogena Light Therapy Aging Mask+

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

LC VASCULAR

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS S.C.S.·Product code IZI·July 2, 2007

GE LOGIQ E9

FDA Adverse Event
Injury ·GENERAL ELECTRIC·Product code IYO·December 12, 2016

LC VASCULAR

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS S.C.S.·Product code IZI·July 2, 2007