8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
CARY BLAIR TRANSPORT MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
GRADUATED GUIDE WIRE BOWL 8
FDA 510(k)
FDA Class 2
·Cardiovascular
ALKALINE PHOSPHATASE REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GREENFIELD
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DTK·April 7, 2020
ENDOWRIST ONE VESSEL SEALER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 10, 2014
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 11, 2010
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 10, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021