9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
VENTED I.V. TRANSFER NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102459·ANIS PHACO CHOPPER, RIGHT
MOUNTAINEER OCT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ROCHE ONLINE TDM QUINIDINE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DC EXTENSION CABLE
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·February 10, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 14, 2012
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Malfunction
·MEDTRONIC SPINE LLC.·Product code NDN·September 3, 2010
EVOLUT FX VALVE
FDA Adverse Event
Injury
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025
NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604412, 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