9 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FITBONE® Transport and Lengthening System
FDA 510(k)
FDA Class 2
·Orthopedic
INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG
FDA Adverse Event
Malfunction
·BIOMET 3I·Product code NDP·May 21, 2021
CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
FDA 510(k)
FDA Class 2
·Orthopedic
SURGIQUEST AIRSEAL IFS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, PUERTO RICO, B.V.·Product code MGB·November 14, 2008
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 2, 2011
SELOX ST 60
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·July 17, 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