7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
VISIVOX, MODEL V-2
FDA 510(k)
FDA Unclassified
·Unknown
KardiaMobile, KardiaStation
FDA 510(k)
FDA Class 2
·Cardiovascular
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFERIOR PLATE
FDA Adverse Event
Injury
·SYNTHES (USA) BRANDYWINE·Product code MJO·February 26, 2013
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·January 14, 2011
COULTER LH 780 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·August 6, 2014
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026