7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
FDA 510(k)
FDA Class 2
·Anesthesiology
NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L
FDA 510(k)
FDA Class 2
·Cardiovascular
AMICUS Separator System, AMICUS Separator System; Refurbished
FDA 510(k)
FDA Class 2
·Hematology
MINIX ST
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code LWO·June 10, 2014
SIGMA 300 DR
FDA Adverse Event
MEDTRONIC MED REL, INC.·Product code DXY·October 8, 2010
ENSEAL SUPER JAW
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·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