9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ONE DRAM SHELL VIAL, CATALOG #02-261
FDA 510(k)
FDA Class 1
·Hematology
MIRADA RTX
FDA 510(k)
FDA Class 2
·Radiology
OPTICAL LOW COHERENCE REFLECTOMETRY (OLCR) PACHYMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 21, 2015
TERUMO CDI 100 MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·November 24, 2010
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·January 22, 2013
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 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