9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TWO TANK DISSOLUTION MODULE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198383·AK3 PS Insert Trial Size 6, 12mm
AMT Suture Delivery System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNGO.PLAZA
FDA 510(k)
FDA Class 2
·Radiology
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZE·December 22, 2009
LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·June 25, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 2, 2013
DUROM US ACETABULAR COMPONENT 52/46 L
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·November 2, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020