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

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    OXYCON PRO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CAPSTONE PTC™ Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169187498·SPACER 3992214 22MM X 14MM

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198536·AK3 Ultra Insert Trial Size 2, 14mm

    CarboClear VBR System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CHIROPRO L SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    OPEN SPINE ANGLED CLAMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 14, 2013

    MEMORY SOFT WIRE BASKET

    FDA Adverse Event
    Injury ·WILSON-COOK MEDICAL INC·Product code FFL·March 1, 2013

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 15, 2011

    CAPSURE SP

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·August 8, 2014

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Enforcement
    Class II ·Terminated·Nobel Biocare Usa Llc·November 20, 2013

    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

    FDA Recall
    Terminated ·Nobel Biocare Usa Llc·Product code EBW·October 24, 2013

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017