11 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MR Conditional Cup Electrode, MR Conditional Webb Electrode
FDA 510(k)
FDA Class 2
·Neurology
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704511093·
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
FDA 510(k)
FDA Class 2
·Orthopedic
IMED-Z FLUID STATUS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·September 19, 2008
T-HANDLE INSERTER
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·April 29, 2021
T-HANDLE
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·May 2, 2023
IMPLANT INSERTER SH CONNECTION
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·May 2, 2023
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