10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TONOMITOR (TM) + SUMP
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
Archon
FDA UDI
Nuvasive, Inc.·00887517072849·Archon ACP Plate, 34mm, 2-Level
K883239
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 24, 2009
CAPD DISP DISCONNECT, UV FLASH
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code KDJ·May 23, 2008
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ESKACHEM PAP REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INS8401 WITH ONLY CM OF H20 READINGS
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES PR·Product code JXG·October 20, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 7, 2014
TI MATRIX LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·December 21, 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