8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
OXYGEN CONNECTING TUBE #017205
FDA 510(k)
FDA Class 1
·Anesthesiology
TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
FDA 510(k)
FDA Class 2
·Cardiovascular
Calix-C Cervical Interbody Spacer
FDA 510(k)
FDA Class 2
·Orthopedic
SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
FDA Adverse Event
Injury
·ETHICON INC.·Product code GDW·April 24, 2014
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·October 3, 2012
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 14, 2015
NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015
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