7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ULTRAFIL-LT (GUTTA PERCHA)
FDA 510(k)
FDA Class 1
·Dental
FUJIFILM Ultrasonic Endoscope EB-710US
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
IMAGER II ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NX3
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·June 5, 2014
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·November 20, 2012
SUMMIT BASIC CEMENTED SZ 3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·September 28, 2010
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021