BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)

    FDA 510(k)
    FDA Class 2 ·Hematology

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017835·K-Wire, Double Ended, Trocar Point, Diameter Si...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613084875·K-Wire, Double Ended, Trocar Point, Diameter 0....

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613084882·K-Wire, Double Ended, Trocar Point, Diameter 0....

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613084899·K-Wire, Double Ended, Trocar Point, Diameter 0....

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193024220·B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 100 MM

    MODIFICATION TO: SATELLITE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 3 ·Unknown

    ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 23, 2025

    V.A.C. GRANUFOAM DRESSING

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020

    SATELLITE SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code NVR·May 5, 2011

    MAXIMO VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 10, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 20, 2014

    VENA CAVA FILTER SYSTEM

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·October 20, 2015

    Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark I Benchtop Incubator (AY102295). The Mark I model is no longer produced, but the legacy humidifier bottle component design can also be used with the BT37 Mark II Benchtop Incubator.

    FDA Enforcement
    Class II ·Ongoing·CooperSurgical, Inc.·October 5, 2022