11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reusable Silicone Cover CPRmeter 2
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517567703·CoRoent Ant TLIF PEEK, 8x13x34mm 8°
DIGIVIEW 250
FDA 510(k)
FDA Class 2
·Radiology
IMAGE-ARENA APPLICATIONS
FDA 510(k)
FDA Class 2
·Radiology
CARTIVA IMPLANT
FDA Adverse Event
Injury
·CARTIVA, INC·Product code PNW·November 13, 2020
CARTIVA IMPLANT
FDA Adverse Event
Injury
·CARTIVA, INC·Product code PNW·November 9, 2020
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 18, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 21, 2013
AMPLATZER® SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·July 28, 2011
Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·April 24, 2019
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