10 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Intraskan DC Plus
FDA 510(k)
FDA Class 2
·Dental
RHEAD
FDA UDI
Stryker GmbH·00886385023748·Resection Guide
ENTERPRISE ELECTROPHYSIOLOGY SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
PERIMETER C SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·October 14, 2014
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 2011
CONFIDENCE SPINAL CMT SYS, 11C
FDA Adverse Event
Injury
·DEPUY SYNTHES SPINE·Product code NDN·June 14, 2013
CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DYB·August 31, 2021
CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code DYB·June 8, 2021
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