BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    AM. PH. STERILE PLASTIC CONNECTING TUBES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113232·PS Insert, Size 4 x 12mm

    MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

    Device
    EU MDR · Eu Md Class 1 ·On the market

    3M SPOTON TEMPERATURE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEPILASE TWIN LASE LASER SYSTEM

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

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 5, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·May 30, 2024

    LIFE PAK

    FDA Adverse Event
    Injury ·PHSIOCONTROL·Product code MKJ·January 27, 2010

    EXCITE F DSC

    FDA Adverse Event
    Malfunction ·IVOCLAR VIVADENT AG·Product code KLE·November 27, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 5, 2015

    SMART PORT CT

    FDA Adverse Event
    Injury ·ANGIODYNAMICS, INC.·Product code LJT·March 30, 2026

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    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