8 results
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26ms
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Sources: EU EUDAMED, US FDA
SHIMADZU MULTI-DIRECTIONAL DIAGNOSTIC TABLE VS-100
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613023430·Plastic Scissors, Curved, Flat Round Shanks, Bl...
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System
FDA 510(k)
FDA Class 2
·Cardiovascular
ALTRUA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 14, 2013
ESSURE
FDA Adverse Event
Malfunction
·CONCEPTUS, INC.·Product code HHS·November 19, 2010
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 3, 2014
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