12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OptoWire Deux
FDA 510(k)
FDA Class 2
·Cardiovascular
TrabecuLink Tibial Cone
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575187799·TrabecuLink Tibial Cone / right half
TrabecuLink Tibial Cone
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575076536·TrabecuLink Tibial Cone / full
TrabecuLink Tibial Cone
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575192403·TrabecuLink Tibial Cone / left half
TrabecuLink Tibial Cone
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575192410·TrabecuLink Tibial Cone / half
M5 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
RADIANCY FACIAL SKINCARE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 27, 2024
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 8, 2014
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·July 7, 2011
ATTAIN ABILITY
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code OJX·June 8, 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