10 results
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19ms
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Sources: EU EUDAMED, US FDA
XC11 ICE System, USA
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFESIGN DXPRESS, MODEL LSR2000
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys Progesterone III Cal Check 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OPTETRAK KNEE COMPONENT - TIBIAL INSERT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 8, 2024
OPTETRAK KNEE COMPONENT - TIBIAL INSERT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 8, 2024
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 16, 2011
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·November 14, 2014
SYSTEM, PERITONEAL AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 29, 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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018