7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PHASE II CORTISOL KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DESERET DENTRAL LINE CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 10, 2014
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 12, 2010
3.5MM LCP PLATE 7 HOLES 98MM
FDA Adverse Event
Injury
·SYNTHES·Product code KTT·December 10, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021