10 results
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18ms
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Sources: EU EUDAMED, US FDA
CARDON PHYSICAL THERAPY TABLE MODEL R28535
FDA 510(k)
FDA Class 1
·Physical Medicine
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·04260516877183·SICvantage Gingiva Shaper red, anterior, concav...
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9503601·SICvantage Gingiva Shaper red, anterior, concav...
Guided Reamer
FDA UDI
BICON, LLC·00813110026569·5.0 x 6.0mm Guided Reamer
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
TULIP CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ACCESS
FDA Adverse Event
Malfunction
·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·February 8, 2013
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·December 14, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 22, 2014
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