BEUDAMED
    18 results · 28ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    FloSure Ventilation Patch

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304239807·

    AGXO

    FDA UDI
    Oticon A/S·05707131289049·H110V2 TI, RITE 312 WL SIL AGXO

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100141·KRATZ-BARRAQUER HEAVY WIRE SPECULUM

    Ophthalmic Speculum

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

    Femoral Cutting Block Size 4

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215074395·

    SUREFIRE INFUSION CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATRICURE ISOLATOR TRANSPOLAR PEN

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·January 16, 2017

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 6, 2013

    SYNCHRON LX20 PRO SYSTEM

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

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    ATRICURE BIPOLAR SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

    EOS PMP, EOS PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2021

    DIDECO EOS ECMO M PHISIO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·May 13, 2021

    SORIN LIFEKIT D905 EOS ECMO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 14, 2021

    EOS PMP, EOS PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·March 23, 2022

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

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