9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM
FDA 510(k)
FDA Class 1
·Dental
Biogel
FDA UDI
Bosma Enterprises·10818634023862·Biogel Skinsense Indicator Underglove Surgical ...
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED
FDA 510(k)
FDA Class 2
·Orthopedic
M2A-MAGNUM 42-50MM TPR INSRT-6
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 31, 2013
UNK
FDA Adverse Event
Malfunction
·CONMED·Product code GEI·June 9, 2011
CD HORIZON AGILE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code NQP·August 28, 2008
UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KOB·May 2, 2018
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