8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ADVANCE DISPOSABLE PRESSURE TRANSDUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
Stern Snap One Piece Abutment 2mm Cuff (BG)
FDA UDI
STERNGOLD DENTAL LLC·00841549112331·SternSnap Overdenture Implant Abutment System t...
HOLLOW MOTOR DRIVE UNIT
FDA 510(k)
FDA Class 2
·Cardiovascular
SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY
FDA 510(k)
FDA Class 2
·Cardiovascular
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA·Product code NIQ·November 22, 2010
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014
MERIDIAN FILTER SYSTEM - JUGULAR
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·December 5, 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