9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CoreDx Pulmonary Mini-Forceps
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515027541·Beckman-Weitlaner Retractor, hinged arms, 3x4, ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694045049·SmartFlex Spring - Small - 8.5N
TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
VENUS BASIC SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code OSI·June 21, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·July 28, 2011
MEDTRONIC 6949
FDA Adverse Event
Malfunction
·MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT·Product code LWS·September 23, 2008
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