12 results
·
37ms
·
Sources: EU EUDAMED, US FDA
RoVo Mechanical Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
LANDANGER
FDA UDI
LANDANGER·03661219331735·
Truliant
FDA UDI
Exactech, Inc.·10885862556929·TRULIANT CC INSRT TOPPER SIZE 3 THIN
ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control
FDA 510(k)
FDA Class 2
·Microbiology
MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
FDA 510(k)
FDA Class 2
·Cardiovascular
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 4, 2026
BD ULTRA-FINE¿ III PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·March 8, 2022
CONTAK RENEWAL 3
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008
AUTOJECT
FDA Adverse Event
Malfunction
·OWEN MUMFORD LTD.·Product code KZH·August 19, 2011
INTERLOCK?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KRD·July 30, 2013
BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 8, 2018
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025