BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    QUICKCAT EXTRACTION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00600921·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0600020·Tray Insert, Level 2

    XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    TEMPHASE

    FDA 510(k)
    FDA Class 2 ·Dental

    COMPLETE DOUBLE MOIST

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code LPN·October 14, 2014

    COMPR 12MM IM HMRL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·April 1, 2019

    PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HRS·April 16, 2013

    *

    FDA Adverse Event
    Malfunction ·MEDLINE INDUSTRIES, INC.·Product code GCY·April 7, 2011

    SENSATION JUMBO OVAL (SGL)

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code KNS·June 4, 2008

    UNKNOWN

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 2018

    Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024