9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
Arthrex®
FDA UDI
ARTHREX, INC.·00888867125889·HEADLESS COMPRES SCRW 4.3X20MM
MANUAL SURGICAL INSTRUMENTS FOR GENERAL USE
FDA 510(k)TCBS
FDA 510(k)
FDA Class 1
·Microbiology
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 10, 2014
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 7, 2010
PINNACLE SECTOR II CUP 54MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910 ·Product code LPH·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
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015