9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
XOMED-TREACE POSITROL FOOTPEDAL SUCTION CONTROL
FDA 510(k)
FDA Class 2
·General Hospital
SORING GMBH SONOCA 180/190
FDA 510(k)
FDA Unclassified
·Unknown
NeuralScan System
FDA 510(k)
FDA Class 2
·Neurology
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR LLC·Product code OBR·May 14, 2014
SENSORMEDICS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code LSZ·November 12, 2010
UNKNOWN RIGHT HIP NECK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 7, 2013
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·October 15, 2025
GENESIS UNI KNEE FEMORAL COMPONENT COCR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·May 23, 2025
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