7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LMD GIARDIA ANTIGEN DETECTION ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
CENTURY SAF-LIFT SCALE
FDA 510(k)
FDA Class 2
·General Hospital
MEDI-KLEER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REAGENT RED BLOOD CELLS BIOTESTCELL 1&2
FDA Adverse Event
Malfunction
·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·February 6, 2013
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·January 3, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 18, 2014
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015