8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DISPOSABLE SHADOW TRAY INSERTS
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994287823·CASE 9871215 TRAY
VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QiF Blood and Fluid Warmer
FDA 510(k)
FDA Class 2
·General Hospital
ATS 3000 TOURNIQUET
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·April 16, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 12, 2012
PINN MAR NEUT 36IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 26, 2015
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