14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Durex Patronus CloseFit, Durex Patronus Regular
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Uni-Flo
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005411·Uni-Flo™ Fenestrated Catheter – 2.5 inch (63.5 ...
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120845·LATERAL,SPACER 17,55X7.5,0 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120821·LATERAL,SPACER 17,45X7.5,0 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120838·LATERAL,SPACER 17,50X7.5,0 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120869·LATERAL,SPACER 17,65X7.5,0 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120814·LATERAL,SPACER 17,40X7.5,0 DEG
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996120852·LATERAL,SPACER 17,60X7.5,0 DEG
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
FDA 510(k)
FDA Class 2
·Hematology
TISSUE OF ORIGIN TEST KIT FFPE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·November 4, 2008
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 18, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
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