BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    Acryfree Denture Base Material and Biosens Denture Base Material

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768482·GENUMEDI PSS GREEN IV

    Oticon

    FDA UDI
    Oticon A/S·05707131288998·H11V2 TI, RITE 312 WL DBL

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304239753·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100127·KRATZ-BARRAQUER SPECULUM RIGHT EYE

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE

    Femoral Cutting Block Pin

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215074425·

    OMNITECH FULGURATING ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V

    FDA 510(k)
    FDA Class 2 ·Neurology

    OSS POROUS IM STEM 18.5 X 225

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 17, 2017

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018

    EZ-PRO R4 AMBUL COT OBS(5/08)

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 6, 2013

    SYNCHRON LX20 PRO SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 8, 2011

    NAVILYST MEDICAL (FORMERLY NAMIC/VA)

    FDA Adverse Event
    Injury ·NAVILYST MEDICAL·Product code LJS·September 5, 2008

    OSS SEGMENTAL ELLIPTICAL FEMORAL 7 CM RIGHT POROUS COATED

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·July 6, 2017

    ASAHI GLADIUS EX

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025

    ASAHI GLADIUS EX

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026

    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016