8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CT 5300
FDA 510(k)
FDA Class 2
·Radiology
McKesson
FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·10612479267821·ADMIN KIT: UNIVERSAL-100 -DS (PED)
MUELLER HINTON AGAR
FDA 510(k)
FDA Class 2
·Microbiology
ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
GE OEC 9400
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008
CANE, CRUTCH AND WALKER TIPS AND PADS
FDA Adverse Event
KENSTONE METAL·Product code INP·September 2, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
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