9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SINGLE PATIENT USE NASAL (CPAP) CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189428·Apex Revision Knee System - Revision Tibia Ream...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189411·Apex Revision Knee System - Revision Tibia Ream...
CONDUCTOR CORONARY GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
FDA 510(k)
FDA Class 2
·Orthopedic
11/13 S-ROM 40MM M SPEC-3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·June 24, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 22, 2010
ELLIPSE DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·December 28, 2012
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