8 results
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18ms
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Sources: EU EUDAMED, US FDA
STAT TEST KIT FOR EB-VCA IGG ANTIBODY
FDA 510(k)
FDA Class 1
·Microbiology
Exciplex
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CENTRY 2 SYSTEM #016, 103, 016, 104
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 31, 2014
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 22, 2010
AXON ECLIPSE DIGITAL PREAMP
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code GWF·December 20, 2012
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
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014