9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TDX SALICYLATE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
PROTECT DROPS/SAME AS K874070
FDA 510(k)
FDA Class 2
·Dental
IMMPULSE SYSTEM
FDA 510(k)
FDA Class 1
·Immunology
EGG YOLK AGAR PLATE
FDA 510(k)
FDA Class 1
·Microbiology
SOLA 500/700
FDA Adverse Event
Malfunction
·DRAEGERWERK AG & CO. KGAA·Product code FTD·August 9, 2018
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 2, 2014
CANES
FDA Adverse Event
PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IPS·November 25, 2012
GUARDIAN FOREARM CRUTCH
FDA Adverse Event
Injury
·PROFIT COUNTRY ENTERPRISES LTD·Product code IPR·September 2, 2010
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