9 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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27HJ713S
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PURITAN BENNETT LEGENDAIR XL2
FDA 510(k)
FDA Class 2
·Anesthesiology
I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 7, 2017
BD PEGASUS PNK 20GA X 1.16IN PRN
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·April 7, 2024
ALARIS SECONDARY ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·June 5, 2013
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 22, 2011
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