13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
T1/T2/T3 TURBINE FAMILY
FDA 510(k)
FDA Class 1
·Dental
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131319·TiBase BC NP 1.5G E
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450190111·
OSTEO-G BONE VOID FILLER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMMULISA DSDNA ANTIBODY ELISA
FDA 510(k)
FDA Class 2
·Immunology
GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 16, 2020
GMK-PRIMARY FEMUR PS CEMENTED SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2019
GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 23, 2017
GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 25, 2018
PELVICOL 2 X 4 CM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE·Product code FTL·May 17, 2013
ALARIS PUMP MODULE SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·September 19, 2014
TOPAZ 3
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·June 16, 2011
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