35 results
·
61ms
·
Sources: EU EUDAMED, US FDA
TRITON CANISTER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP·Product code PBZ·April 27, 2023
ADVANCED BIONICS U.S. PAT. 366 HIRES 9011
FDA Adverse Event
Injury
·CANNON TECHNOLOGIES INC·Product code MCM·April 23, 2010
ON-X AORTIC ANATOMIC EXT 21
FDA Adverse Event
Death
·ON-X LIFE TECHNOLOGIES, INC.·Product code LWQ·July 8, 2020
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
FDA Recall
Terminated
·Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Seocho-Daero, Seocho # 413 398 Platinum Tower Seoul Korea (the Republic of)·Product code EXY·April 21, 2022
DEXCOM G6
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·December 22, 2025
AIR SENSE 10 AUTO SET
FDA Adverse Event
Injury
·RESMED CORP.·Product code BZD·September 7, 2022
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices
Front Line Medical Technologies Inc.
System producer
🇨🇦 Canada
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
FDA Recall
Terminated
·On-X Life Technologies, Inc.·Product code PAW·December 13, 2016
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
FDA Recall
Open, Classified
·On-X Life Technologies, Inc.·Product code LWQ·February 1, 2026
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
FDA Enforcement
Class II
·Ongoing·On-X Life Technologies, Inc.·May 20, 2026
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.
FDA Enforcement
Class II
·Terminated·On-X Life Technologies, Inc.·February 1, 2017
Kaster S.r.l.
Importer
🇮🇹 Italy·5 Manufacturers
Life Technologies Europe B.V.
Importer
🇳🇱 Netherlands·6 Manufacturers
28620163227
Certificate
MDR Technical Documentation·Front Line Medical Technologies Inc.·Intertek Medical Notified Body AB
28620163227
Certificate
MDR Technical Documentation·Front Line Medical Technologies Inc.·Intertek Medical Notified Body AB·1 Basic UDI-DI
MEDISYNER s.r.o.
Importer
🇨🇿 Czechia·5 Manufacturers
VASCULAR THERAPY
Importer
🇫🇷 France·6 Manufacturers
TapMed Medizintechnik Handels GmbH
Importer
🇩🇪 Germany·10 Manufacturers
AB Medical Group Eesti OÜ
Importer
🇪🇪 Estonia·8 Manufacturers