8 results
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26ms
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Sources: EU EUDAMED, US FDA
CLEARSITE(R) STERILE WOUND CARE DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIOPRO TRINITY ACETABULAR CUP
FDA 510(k)
FDA Class 2
·Orthopedic
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·December 3, 2010
UPHOLD? LITE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTP·July 3, 2014
RAPID RESORBABLE CRANIAL CLAMP 18MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GXR·December 7, 2012
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
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