BEUDAMED
    16 results · 28ms · Sources: EU EUDAMED, US FDA

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    GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP

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

    HIP BROACH HANDLE, GEN 2, OFFSET LEFT

    FDA UDI
    Conformis, Inc.·00810933031664·HIP BROACH HANDLE, GEN 2, OFFSET LEFT

    NA

    FDA UDI
    STRYKER CORPORATION·07613327058628·Insert, Tenaculum Forceps

    AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV

    FDA 510(k)
    FDA Class 2 ·Neurology

    MASTERSCREEN CPX AND OXYCON CPX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LINEAR 3-4

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 29, 2024

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 21, 2017

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 20, 2020

    AVISTA? MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 23, 2025

    ENDO STITCH PLYSORB 0 48 VIO DLU SU

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

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 6, 2011

    GALILEO

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

    ZILVER 518 SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 26, 2012

    GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 30, 2014

    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