11 results
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28ms
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Sources: EU EUDAMED, US FDA
STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252047400·ceraMotion® Me Dentin B2, 40 g / dental ceramic...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252047900·ceraMotion® Me Dentin B2, 240 g / dental cerami...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252047200·ceraMotion® Me Dentin B2, 20 g / dental ceramic...
INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
FDA 510(k)
FDA Class 2
·Orthopedic
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STERIS 40 STERILANT
FDA Adverse Event
STERIS CORPORATION-HOPKINS·Product code MED·September 16, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014
ENDURANT II
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 29, 2013
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN 83 UNITS
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·April 16, 2026
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