7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DYLADE, MODEL DS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEONATAL RESUSCITATOR, SAMSON
FDA 510(k)
FDA Class 2
·Anesthesiology
ORTHADAPT BIOIMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
5CM HEAVY DUTY SHORT ATTACHMENT
FDA Adverse Event
Injury
·DEPUY SYNTHES POWER TOOLS·Product code HBC·April 24, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·October 3, 2012
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2010
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014