21 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INVISION Total Ankle Revision System
FDA 510(k)
FDA Class 2
·Orthopedic
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
LACTOSORB® SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036056049·
Biomet
FDA UDI
Provision·B504OM91530080·
LEONE SPA
FDA UDI
LEONE SPA·08033707014621·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 8
MultiStage®
FDA UDI
Dongguan TT Medical, Inc.·06934184004506·
MultiStage®
FDA UDI
Dongguan TT Medical, Inc.·06934184004148·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197496056·RZ Rainer Ring Curettes
straig...
E-Z-EM ENDOSCOPIC CO2 REGULATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INZONE DETACHMENT SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025
AXIOS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 17, 2024
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025
AXIOS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·MEDTRONIC INC·Product code DTB·June 8, 2013
POLYFLUX R CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008
ENDURANT STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·June 23, 2011
AXIOS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024
BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMI·November 4, 2021