8 results
·
35ms
·
Sources: EU EUDAMED, US FDA
DIASTAT ANTI-HISTONE KIT
FDA 510(k)
FDA Class 2
·Immunology
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113393·PS Insert, Size 6 x 16mm
BAYER RAPIDPOINT 405 SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NKB·January 17, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·December 13, 2010
ENDURITY DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021