7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
WIDEX MODEL LOGO 6 (L6)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SYNGO, CT LIVER ANALYSIS
FDA 510(k)
FDA Class 2
·Radiology
CO2 CALIBRATOR/DILUENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·January 29, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 17, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 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