8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DIFCO OXIDASE DRYSLIDE
FDA 510(k)
FDA Class 1
·Microbiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756672498·EXTREMITY PACK
RETRACTOR RODS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RYAN-STYLE DIRECTED INFUSION MANIPULATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCENT DR RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 16, 2014
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·WALDEMAR LINK, GMBH & CO.·Product code HSN·December 28, 2012
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