7 results
·
16ms
·
Sources: EU EUDAMED, US FDA
IMMUNOGLOBULIN M NEPHEL. ASSAY
FDA 510(k)
FDA Class 2
·Immunology
Lyme B. burgdorferi (IgM) MarStripe Test
FDA 510(k)
FDA Class 2
·Microbiology
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
SUPER POLIGRIP FREE DENTURE ADHESIVE CREAM
FDA Adverse Event
Other
·GLAXOSMITHKLINE·Product code KOL·March 27, 2014
SYMBIQ 3.13 DUAL CHA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 2, 2012
SERIES 20000 LEGACY
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 22, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021