10 results
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19ms
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Sources: EU EUDAMED, US FDA
SPIRIT CHEMISTRY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18331161·
Masel
FDA UDI
Ortho Organizers, Inc.·00190707034962·.016 Upper Elastinol™ Natural Orthocosmetic Arc...
OPTI-RIDER DELUXE
FDA 510(k)
FDA Class 2
·Physical Medicine
VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC
FDA 510(k)
FDA Class 2
·General Hospital
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·November 6, 2012
HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR
FDA Adverse Event
Malfunction
·TELEFELX MEDICAL·Product code BTT·March 24, 2014
TRIATHLON-CR FEMORAL COMPONENT CEMENTED #6 RIGHT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·September 9, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020