10 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
artegral
FDA UDI
Merz Dental GmbH·D7091972220·posteriors; shade A3.5 light; size XL; upper jaw
Bioseal Inc.
FDA UDI
BIOSEAL·00630094197227·Silicone Tubing 18"
Advanced Perfusion System 1
FDA 510(k)
FDA Class 2
·Cardiovascular
PEDI CO2 EASY
FDA 510(k)
FDA Class 2
·Anesthesiology
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 21, 2013
GORE PROPATEN VASCULAR GRAFT
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES,INC·Product code DSY·January 21, 2011
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 31, 2014
PECTUS SYSTEM JANTON 12" TI PECTUS BAR 3.048CM (12") (L) TITANIUM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 2, 2019
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