11 results
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20ms
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Sources: EU EUDAMED, US FDA
Disposable Vinyl Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Blade Scalpel
FDA UDI
KATENA PRODUCTS, INC.·00841668113509·MINIATURE BLADE #67 (BX/5)
BRAIN VIEWRX VIEWER, VERSION 1.0
FDA 510(k)
FDA Class 2
·Radiology
Touch Ultrasound
FDA 510(k)
FDA Class 2
·Radiology
BD BBL¿ CDC ANAEROBE 5% SHEEP BLOOD AGAR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·March 17, 2022
PLATE CDC ANAEROBE 5% SB 100 EA JP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSG·April 2, 2021
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 17, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 29, 2013
BD BBLTM CDC ANAEROBE 5% SHEEP BLOOD AGAR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·August 18, 2022
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