9 results
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18ms
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Sources: EU EUDAMED, US FDA
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
FDA 510(k)
FDA Unclassified
·Unknown
Gyrus ACMI
FDA UDI
Gyrus ACMI, LLC·00821925040311·BIVALVE SPLINT, LARGE THICK. SHORT-TERM USE UP ...
KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
ST Internal Implant System
FDA 510(k)
FDA Class 2
·Dental
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
EON MINI
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 4, 2014
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·October 28, 2010
BRILLIANCE 64
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·December 21, 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