11 results
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20ms
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Sources: EU EUDAMED, US FDA
Sight OLO
FDA 510(k)
FDA Class 2
·Hematology
CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER
FDA 510(k)
FDA Class 2
·Cardiovascular
S.C.O.R.E.S. UNIT
FDA 510(k)
FDA Class 2
·General Hospital
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·July 30, 2019
USS LOW PROFILE FRACTURE CLAMP
FDA Adverse Event
Injury
·SYNTHES MEZZOVICO·Product code NKB·October 21, 2014
ACRYSERT DELIVERY SYSTEM
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·July 28, 2011
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 14, 2013
PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 28, 2018
DISTAL FEMUR JTS
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE·Product code KRO·October 15, 2018
DISTAL FEMUR JTS / PROXIMAL TIBIA MIG
FDA Adverse Event
Injury
·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·April 7, 2015
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