9 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MERIDIAN TITANIUM FEMORAL STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
artegral
FDA UDI
Merz Dental GmbH·D7091972228·posteriors; shade A3.5 light; size XS; upper jaw
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
pioli IOL Delivery System
FDA 510(k)
FDA Class 1
·Ophthalmic
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·February 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 31, 2014
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR·Product code DQX·January 24, 2011
ENDOPATH ETS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·May 8, 1997
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