8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CHEMSTRIP MINI UA URINE ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC
FDA 510(k)
FDA Class 2
·Microbiology
REPROCESSED ENDOSCOPIC TROCAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2014
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·February 5, 2013
ARSTASIS ACCESS SYSTEM
FDA Adverse Event
Other
·ARSTASIS INC.·Product code DYB·December 9, 2010
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·July 8, 2019
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