12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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End Cap
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BIORCI
FDA UDI
Smith & Nephew, Inc.·00885556603413·MTO BIORCI DRIVER W/GRAD MARKS TO 60MM
NA
FDA UDI
Smith & Nephew, Inc.·03596010102737·TWIST DRILL LARGE 12.7MM X 127MM
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450413418·
SELECTRA CS LEAD INTRODUCER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVIA RETIC PLUS
FDA 510(k)
FDA Class 2
·Hematology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 29, 2014
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·August 9, 2011
CURRENT RF VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code FCG·December 6, 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