11 results
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19ms
·
Sources: EU EUDAMED, US FDA
Veloxion System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304254855·
NEXGEN PERIPHERAL GUIDE CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
THYROSAMPLER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 10, 2014
POLARIS 5.5 SYSTEM IMPLANTS
FDA Adverse Event
Malfunction
·EBI, LLC.·Product code KWP·June 11, 2013
UNICEL DXL800 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 15, 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