BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    TUFF-TEMP 2.0

    FDA 510(k)
    FDA Class 2 ·Dental

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319704035·Iris Dressing Forceps 4" (10cm), full curved, s...

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 21, 2024

    JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UC-CARE NAVIGO SYTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2013

    CALCIUM ARSENAZO REAGENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CJY·June 10, 2011

    STARCLOSE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·August 15, 2008

    NEEDLE 16X1 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·June 6, 2024

    ASAHI GLADIUS MG14 PV ES

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·November 9, 2023

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    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