BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HIP BROACH HANDLE, GEN 2, NEUTRAL

    FDA UDI
    Conformis, Inc.·00810933031640·HIP BROACH HANDLE, GEN 2, NEUTRAL

    QUICK COMBO PAD

    FDA Adverse Event
    Injury ·PHYSIO CONTROL CORP.·Product code MLN·January 17, 1997

    MACROPOREMX MANDIBULAR FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BECKMAN COULTER DNASE B CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD SYRINGE 20ML L/T SSU NRFIT

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code QEH·December 4, 2025

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 23, 2024

    ENDO STITCH 10MM SUTURING DEVICE

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY US SUR·Product code KOG·April 9, 2013

    NEVER TOUCH VENACURE

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS, INC.·Product code GEX·April 14, 2008

    RENEGADE FIBER BRAIDED MICROCATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KRA·May 6, 2011

    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