8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE
FDA 510(k)
FDA Class 2
·Anesthesiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150775·K-WIRE - SINGLE TROCAR 2.0mm DIA x 230mm
BIOLOX DELTA CERAMIC HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
PARIETENE MACROPOROUS MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TAXUS® EXPRESS²®
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·February 4, 2013
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·November 11, 2010
HCG ONE STEP PREGNANCY TEST DEVICE (URINE/SERU)
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·March 4, 2014
Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 2, 2016