14 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Instant 20s Indicator
FDA 510(k)
FDA Class 2
·General Hospital
TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
FDA 510(k)
FDA Class 1
·Dental
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·October 13, 2016
CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·December 6, 2016
MEDLINE UNITE
FDA Adverse Event
Injury
·MEDLINE INDUSTRIES, LP·Product code JDR·December 23, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 13, 2014
TECNIS
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HQL·August 12, 2011
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013
CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·September 30, 2016
INSERTION HANDLE FOR SUPRAPATELLAR
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code JDS·September 30, 2016
CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FZX·December 10, 2014
CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·May 1, 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