11 results
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21ms
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Sources: EU EUDAMED, US FDA
Sherpa Pak Kidney Transport System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017774·K-Wire, Double Ended, Trocar Point, Diameter Si...
MAXIM VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304205604·
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·September 10, 2024
PERIOPATCH
FDA 510(k)
FDA Unclassified
·Unknown
GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 13, 2014
DIMENSION(R) CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code LCP·June 3, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 23, 2011
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 4, 2023
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