15 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HipCheck
FDA 510(k)
FDA Class 2
·Radiology
PROW FUSION
FDA 510(k)
FDA Class 2
·Orthopedic
PICASSO/ PICASSO LITE/ PICASSO PERIO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970515·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970522·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973127·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973554·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973011·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970539·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973417·
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Death
·INTUITIVE SURGICAL,INC.·Product code NAY·October 17, 2014
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·June 10, 2013
ASCENSION MCP PROXIMAL - PROXIMAL TRIAL
FDA Adverse Event
Malfunction
·ASCENSION ORTHOPEDICS, INC.·Product code NEG·July 11, 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