9 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Spine Navigation and Robotic-Assistance Device
FDA 510(k)
FDA Class 2
·Neurology
DART-FIRE EDGE Cannulated Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
BD PREVENTIS 1/2IN HYPAK SAFETY DEVICE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·February 20, 2019
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 6, 2014
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 2, 2011
LASSO® 2515 NAV ECO VARIABLE CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·July 18, 2013
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012