10 results
·
33ms
·
Sources: EU EUDAMED, US FDA
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
CLO-SURPLUS P.A.D.
FDA 510(k)
FDA Unclassified
·Unknown
Irradiation Cosmetic Device
FDA 510(k)
FDA Class 2
·Physical Medicine
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·March 12, 2025
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·March 12, 2025
PERMACOL 10X15 1.5MM
FDA Adverse Event
Death
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013
PRIME BIG WHEEL STRETCHER,30"
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·March 7, 2013
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·February 15, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MPRI·Product code NVY·August 8, 2014
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