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

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    AXIS SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    PROCLUDE

    FDA 510(k)
    FDA Class 1 ·Dental

    DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMP,TSV,4.1MM,SBM,13

    FDA Adverse Event
    Injury ·ZIMVIE US CORP LLC·Product code DZE·October 21, 2025

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTEC)·Product code NEW·November 14, 2008

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009

    UNKNOWN DEPUY ACETABULAR LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·April 23, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 22, 2011

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·March 12, 2009

    IMP,TSV,4.1MM,SBM,10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 21, 2025

    IMP,TSV,4.1MM,SBM,11.5

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 18, 2024

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 1, 2023

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·October 31, 2008

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 7, 2020

    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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012