8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SPECIMEN CONTAINER
FDA 510(k)
FDA Class 1
·Microbiology
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DISPOSABLE LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
KOTEX NATURAL BALANCE : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·KIMBERLY-CLARK CORPORATION CONWAY MILL·Product code HEB·June 21, 2018
ENDO STITCH 10MM SUTURING DEVICE
FDA Adverse Event
Injury
·COVIDIEN·Product code KOG·June 9, 2014
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 11, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·December 28, 2012
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