10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL
FDA 510(k)
FDA Class 2
·Hematology
ABX MINOTROL 16
FDA Adverse Event
Other
·HORIBA MEDICAL·Product code GKZ·June 6, 2013
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776119720·Cervical Retractor Frame, offset frame
MINI OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K85055231·MINI OVATION® Base Rx 022 UL/5-5 CS HK
MINI OVATION®
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K85055241·MINI OVATION® Base Rx 022 UL/5-5 CS-BC MHK
MODIFICATION TO BVBLUE
FDA 510(k)
FDA Class 1
·Microbiology
DS Core Diagnosis
FDA 510(k)
FDA Class 2
·Radiology
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·October 2, 2010
THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GEI·March 20, 2014
REPLY
FDA Adverse Event
Injury
·SORIN CRM S.R.L.·Product code NVZ·November 23, 2012