10 results
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19ms
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Sources: EU EUDAMED, US FDA
IL TEST LIPASE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-BASE, CLP-275, CLP-55.
FDA 510(k)
FDA Class 2
·Physical Medicine
Tapestry Biointegrative Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OSSEOTITE CERTAIN IMPLANT 6 X 8.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·February 26, 2024
SPRINT FIDELIS
FDA Adverse Event
Injury
·MPRI·Product code LWS·February 9, 2013
PALINDROME 19/36 KIT W/SLOT
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·January 4, 2011
CAPSUREEPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVN·July 23, 2014
VIDAS ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·January 21, 2021
VIDAS® ESTRADIOL II
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code CHP·September 16, 2021
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