8 results
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26ms
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Sources: EU EUDAMED, US FDA
SPINAL PAD
FDA 510(k)
FDA Class 2
·Physical Medicine
EASYCARE ONLINE
FDA 510(k)
FDA Class 2
·Anesthesiology
CIBA CORNING MAGIC LITE FOLATE IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SMALL BATTERY DRIVE
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·March 7, 2013
UNK - IOL
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·February 11, 2011
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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