8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
FDA 510(k)
FDA Class 2
·General Hospital
FREEDOM ND: YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AEQUALIS
FDA Adverse Event
Injury
·TORNIER SAS·Product code KWS·May 23, 2013
SECURE II MED/SURG MED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 12, 2011
UNK
FDA Adverse Event
Injury
·I-FLOW CORP.·Product code MEB·August 19, 2008
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
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020