9 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FUKUDA DENSHI MODEL UF-4500
FDA 510(k)
FDA Class 2
·Radiology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123298·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 200mm
Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
FDA 510(k)
FDA Class 2
·Radiology
EXTERNAL FIXATOR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SIDUS® STEM-FREE SHOULDER, HUMERAL ANCHOR, UNCEMENTED, M
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·February 27, 2025
DUROM HIP GENERIC
FDA Adverse Event
Other
·ZIMMER GMBH·Product code KWY·January 15, 2013
MAXIMO II VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 9, 2014
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