11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mitek TIGHT-N Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO ENTEC PLASMA WANDS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SHIGA TOXIN QUIK CHEK
FDA 510(k)
FDA Class 1
·Microbiology
BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·December 4, 2024
BD BACTEC¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code MDB·April 22, 2025
SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·January 16, 2026
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·August 24, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
4000CMS
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 1, 2013
SUMMIT POR TAPER SZ7 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 18, 2019
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