10,000 results
·
50ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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