22 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Cardiovascular
Oticon
FDA UDI
Oticon A/S·05707131259783·RIA PRO, BTE 13 WL 85 TC
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
ITI SYNOCTA MESO ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PLATE, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HRS·October 24, 2015
ALARIS® PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·February 14, 2019
ENDO CLIP III
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code FZP·July 25, 2018
ENDO CLIP
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code FZP·January 24, 2019
VA LOCKSCR Ø2.4 SELF-TAP L12 TAN
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 18, 2013
GOLDENBERG TORP HA/PLAST-PORE
FDA Adverse Event
Injury
·GYRUS ACMI, INC.·Product code ETA·May 24, 2013
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·May 11, 2011
XPAND SPACER SMALL 12X14 3.5/3.5 42-57MME
FDA Adverse Event
Injury
·GLOBUS MEDICAL, INC.·Product code MQP·August 14, 2008
VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·April 27, 2022
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·July 30, 2015
SCREW,FIXATION,BONE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HWC·December 30, 2014
UNK - SCREWS: 2.7 MM VA LOCKING
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·March 1, 2024
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 22, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 24, 2015