9 results
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19ms
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Sources: EU EUDAMED, US FDA
KARL STORZ Laryngoscopes and Accessories
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011252624200·ceraMotion® Me 3D Dentin CC51, 20 g / dental ce...
XSTAT 30, 3-PACK, XSTAT 30, 1-PACK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
A2526-24 SPINAL (SHB) W/DRUGS
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·September 18, 2011
PHILIPS MULTIPARAMETER PATIENT MONITOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 15, 2013
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