7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PERFECTA TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Ceramic Brackets Orthometric
FDA 510(k)
FDA Class 2
·Dental
KANGAROO NASAL MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
STERLING¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·January 18, 2013
RELIA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·December 13, 2010
ENTERRA
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LNQ·July 9, 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