12 results
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23ms
·
Sources: EU EUDAMED, US FDA
Hydris Oral Rinse
FDA 510(k)
FDA Unclassified
·Unknown
MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 - LATER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·December 16, 2020
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
FDA 510(k)
FDA Class 2
·Radiology
SYNGO VIA MI WORKFLOWS
FDA 510(k)
FDA Class 2
·Radiology
MOTO PARTIAL KNEE TIBIAL INSERT FIX S4 LM - 8MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·October 26, 2023
ACIST
FDA Adverse Event
Malfunction
·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·August 1, 2013
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
ALTIUS M-INI IMPLANTS
FDA Adverse Event
Malfunction
·EBI, LLC·Product code KWP·July 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·October 10, 2014
SYRINGE 30ML LL S/C 56
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·April 13, 2021
SYRINGE 30ML LL S/C 56
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·April 13, 2021
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