11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FiteBac Cavity Cleanser
FDA 510(k)
FDA Class 2
·Dental
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319721117·Buck Ear Curette 6-1/2" (16.3cm), size 0, sharp...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804496·Robotti Double Ended Septal Elevator, Large, 17...
SYRINGE 50ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 30, 2025
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
HYDROCOAT MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·October 21, 2014
GENERIC - CELSIUS THERMOCOOL TC
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·August 4, 2011
INTERSTIM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·June 26, 2013
SYRINGE 50ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·January 30, 2025
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