12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Kosmos
FDA 510(k)
FDA Class 2
·Radiology
LEVEL ONE CMF
FDA Adverse Event
Injury
·KLS-MARTIN L.P.·Product code JEY·April 17, 2026
INTONEMV
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHOPEDIC ALLIANCE SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 28, 2025
BD SAFETYGLIDE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·September 14, 2024
BD SAFETYGLIDE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·September 14, 2024
SYNCHRON BILIRUBIN CALIBRATOR
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CIG·September 4, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 6, 2014
GYNECARE PROLIFT +M PELVIC FLOOR REPAIR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·July 18, 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
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025