12 results
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22ms
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Sources: EU EUDAMED, US FDA
VISITRAK, VERSION 1, RELEASE 1
FDA 510(k)
FDA Class 2
·Radiology
LIGHTLAS 532 PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·November 21, 2013
HEMICAP/UNICAP RESURFACING PROSTHESIS
FDA Adverse Event
Other
·ARTHROSURFACE, INC.·Product code HSD·December 7, 2012
VISX EXCIMER LASER
FDA Adverse Event
Injury
·AMO MANUFACTURING USA LLC·Product code LZS·November 5, 2010
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·August 20, 2013
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·October 30, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 10, 2013
ISOFLEX S
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008
ENDOPATH* TROCAR
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GEA·April 12, 2011
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