10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SeaSpine Vu cPOD, Zuma-C, Complete Cervical
FDA 510(k)
FDA Class 2
·Orthopedic
HELONTIX VENT
FDA 510(k)
FDA Class 2
·Anesthesiology
CVC SET: 2-LUMEN 5 FR X 13 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DQY·April 28, 2014
VENTED AUTOFEED CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 21, 2013
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·January 19, 2011
IMMULITE 2000 ESTRADIOL
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024
IMMULITE 2000 ESTRADIOL
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024
IMMULITE 2000 ESTRADIOL
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code CHP·December 6, 2024
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