14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
FDA 510(k)
FDA Class 2
·Cardiovascular
DD cubeY® HL
FDA UDI
Dental Direkt GmbH·EDDIG8440031·The DD cubeY® HL zirconium dioxide milling blan...
SPINNING SPIROS
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·November 2, 2016
MOTILITY INDOLE ORNITHINE-MEDIUM
FDA 510(k)
FDA Class 1
·Microbiology
Electrically powered wheelchair
FDA 510(k)
FDA Class 2
·Physical Medicine
SPINNING SPIROS
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·November 2, 2016
SPINNING SPIROS
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·November 2, 2016
INJECTOR, OPTIVANTAGE DH W/RFID
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM·Product code IZQ·November 4, 2022
SPINNING SPIROS
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FPA·November 2, 2016
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 2, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·November 23, 2012
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·September 13, 2010
INJECTOR, OPTIVANTAGE DH W/RFID
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM·Product code IZQ·October 27, 2023
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