7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
EAGLE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
MED-RX EXTENSION SET WITH T-CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNVISC-ONE (HYLAN G-F 20) INJECTION 6/ML
FDA Adverse Event
Other
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·November 3, 2010
ACCOLADE 132 SIZE 5.5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 7, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 3, 2014
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