BEUDAMED
    21 results · 34ms · Sources: EU EUDAMED, US FDA

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    BLOOD WARMER (CODE 4R4305)

    FDA 510(k)
    FDA Class 2 ·Hematology

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR87600121·Mand. 2. Bicuspidband left 12

    Washbon

    FDA UDI
    ORMCO CORPORATION·00889989043099·LOWER LEFT SECOND MOLAR WASHBON BAND SIZE 12

    RIBFIX BLU SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036184605·

    RIBFIX BLU SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036275310·

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR87600120101·Mand. 2. Bicuspidband left 12

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR87600120051·Mand. 2. Bicuspidband left 12

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR87600120501·Mand. 2. Bicuspidband left 12

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity

    O-pel Laser and families of probe delivery devices

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

    CLIRPATH TURBO PERIPHERAL CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·April 18, 2014

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·September 21, 2012

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 16, 2010

    INFINION? CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 9, 2026

    Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 22, 2023

    Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 29, 2017

    Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 30, 2025