8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
CLINITEST HCG PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PINOOK STIMULATOR
FDA 510(k)
FDA Class 2
·Neurology
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 22, 2015
MESH SLING
FDA Adverse Event
Injury
·Product code FTL·January 25, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2014
DA-400CIII
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EGS·May 26, 2015
GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·July 30, 2014