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

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    SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER

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

    HIP BROACH HANDLE, GEN 2, OFFSET RIGHT

    FDA UDI
    Conformis, Inc.·00810933031657·HIP BROACH HANDLE, GEN 2, OFFSET RIGHT

    NA

    FDA UDI
    STRYKER CORPORATION·07613327058680·Insert, Retention Grasper

    MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UNIQUE AMBULATORY EEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code BRZ·May 6, 2011

    SPACEMAKER PREPERITIONAL DIST BALLOON

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC·Product code GEX·April 9, 2013

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·July 25, 2008

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025

    Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion.

    FDA Recall
    Terminated ·Theken Spine Llc·Product code KWQ·July 29, 2010

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014