10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DIAGNON FOLATE 125I RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704204407·
REFUGE SOUND GENERATOR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)
FDA 510(k)
FDA Class 2
·Radiology
BD BBL¿ HEMO (HAEMOPHILUS) ID QUAD (WITH GROWTH FACTORS)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·February 24, 2022
BRILLANCE 64
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·May 20, 2014
DHS/DCS COMPRESSION SCREW, 36MM
FDA Adverse Event
Injury
·Product code HWC·November 1, 2012
ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·September 10, 2010
Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017