7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
FDA 510(k)
FDA Class 1
·Dental
SUTTER MODEL 10000 LEG CPM DEVICE
FDA 510(k)
FDA Class 1
·Physical Medicine
AIA-PACK AFP CALIBRATION VERIFICATION TEST SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATTAIN OTW
FDA Adverse Event
Injury
·MPRI·Product code LWP·February 15, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
ALARIS PUMP MODULE
FDA Adverse Event
Injury
·CAREFUSION CORPORATION·Product code FRN·July 16, 2014
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020