8 results
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32ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Northern Labs Inc
FDA registration
Northern Labs Inc·1 product·🇺🇸 United States
THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
FDA 510(k)
FDA Unclassified
·Unknown
SQA V, SPERM QUALITY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·May 8, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·September 26, 2014
ESSURE
FDA Adverse Event
Malfunction
·BAYER PHARMA AG·Product code HHS·May 20, 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