7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MODIFIED DDI SEROCARD CMV IGG TEST KIT
FDA 510(k)
FDA Class 2
·Microbiology
PARALLEL FLAME PHOTOMETER & SODIUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IR-192 IMPLANT
FDA 510(k)
FDA Class 2
·Radiology
CVC KIT: 3-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code FOZ·June 11, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 20, 2014
ARCHITECT CA 19-9XR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code NIG·December 21, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024