8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MASK, GAS, ANESTHETIC
FDA 510(k)
FDA Class 1
·Anesthesiology
GDLS-200
FDA 510(k)
FDA Class 2
·Dental
LaparoGuard
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ST FRANCIS HSP TULSA OK 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·December 18, 2012
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·June 18, 2014
HEARTSTART MRX - EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·October 20, 2010
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 20, 2012
ENT Pack - contains Devon Light Glove Used during surgery
FDA Enforcement
Class II
·Completed·Stradis Healthcare, LLC.·July 15, 2015