7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SCEPTOR BETA-LACTAM PLUS MIC PANEL
FDA 510(k)
FDA Class 2
·Microbiology
ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIORAPTOR KNOTLESS
FDA Adverse Event
Malfunction
·MANSFIELD MANUFACTURING SITE·Product code MBI·June 10, 2014
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·Product code KWA·December 10, 2012
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 11, 2010
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