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

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    LUMBOSACRAL SUPPORT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CODMAN® HAKIM®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780519775·CODMAN® HAKIM® Precision Fixed Pressure Valve w...

    CODMAN® HAKIM®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780535003·Precision Fixed Pressure Valve In-Line Valve wi...

    CODMAN HAKIM SIPHONGUARD

    FDA UDI
    Cerenovus, Inc.·10886704041795·CODMAN HAKIM Precision Fixed Pressure Valve In-...

    INTERLIG

    FDA 510(k)
    FDA Class 2 ·Dental

    EASYCUP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROSTHESIS, INTERVERTEBRAL DISC

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·May 21, 2014

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    FDA Adverse Event
    Injury ·XOMED MFG JACKSONVILLE·Product code LRK·October 29, 2012

    STERLING BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·September 2, 2010

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    ACCOLADE SR SL MRI (Model L310)

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

    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