12 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Endoform Silver Dermal Template
FDA 510(k)
FDA Unclassified
·Unknown
CLEARPATH 24
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWRSYRINGE INJECTOR
FDA 510(k)
FDA Class 2
·General Hospital
U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·BERRY PLASTICS QINGDAO LTD.·Product code HEB·October 31, 2022
U BY KOTEX : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·BERRY PLASTICS QINGDAO LTD.·Product code HEB·January 5, 2022
MATRIXMIDFACE SCREWDRIVER BLD W/SPRG HLDG SLV LONG/95MM HXC
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code HXX·February 24, 2017
U BY KOTEX UNKNOWN : TAMPON, MENSTRUAL, UNSCENTED : HEB
FDA Adverse Event
Malfunction
·BERRY PLASTICS QINGDAO LTD.·Product code HEB·June 28, 2023
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·June 5, 2013
4C-ES CELL CONTROL
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JPK·June 24, 2011
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 18, 2008
ULTRAFLEX DUO HIGH FLUID CART
FDA Adverse Event
Malfunction
·DORNOCH·Product code JCX·August 28, 2017
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