8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CRYPTOSPORIDIUM ANTIGEN DETECTION
FDA 510(k)
FDA Class 2
·Microbiology
LACTOSCREW ANCHOR TAP
FDA UDI
Biomet Orthopedics, LLC·00880304457843·
FASTIDIOUS MIC PANEL
FDA 510(k)
FDA Class 2
·Microbiology
TRAMSCOPE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 28, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 11, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021