8 results
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25ms
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Sources: EU EUDAMED, US FDA
NYLAMID SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALT LASER, MODEL VTR 75
FDA 510(k)
FDA Class 2
·Physical Medicine
ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES
FDA 510(k)
FDA Class 2
·Orthopedic
FOUNDATION KNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·January 22, 2013
VASOVIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET, INC·Product code GEI·December 1, 2010
M2A-MAGNUM MODULAR HEAD SZ 42MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·July 14, 2014
HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 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