7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10
FDA 510(k)
FDA Class 2
·Radiology
SFP AGAR PLATES
FDA 510(k)
FDA Class 1
·Microbiology
UNKNOWN CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·June 19, 2014
TI MATRIXRIB UNIVERSAL PLATE 8 HOLES
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HRS·December 22, 2012
SSL ACCESS SYSTEM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·October 27, 2010
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