BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    FIBEROPTIC LIGHT CARRIERS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM

    FDA 510(k)
    FDA Class 2 ·Dental

    PEGASUS NASAL CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 20, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·Product code OYC·November 7, 2012

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·December 3, 2007

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    ACCOLADE SR SL MRI (Model L310)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025