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

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    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100510·Caddie, 5.5mm Screws

    RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Corin BiPolar-i

    FDA UDI
    CORIN LTD·05056139233975·Acetabular Trial Ø51

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521110051D0·10 x 50 mm SI Implant Fully Threaded with HA Co...

    INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 21, 2018

    Various Cysto Packs

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·September 14, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 13, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code CAW·September 23, 2014

    FREESTYLE NAVIGATOR

    FDA Adverse Event
    Malfunction ·Product code LFR·June 1, 2011

    POLY-TAPE, 20 X 500MM

    FDA Adverse Event
    Injury ·XIROS·Product code JDR·December 6, 2011

    UNKNOWN MICROCATHETER

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017

    CABLE, J6, STAGE 2, LOWER SET, UPPER

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 3, 2019

    Video Cystoscope models ECY-1570 and ECY-1570K

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·February 21, 2018

    3.0 RIO® ROBOTIC ARM - MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·August 7, 2019

    LED, PUSHBUTTON AMBER BAYONET

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·August 7, 2019

    Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LNH·August 3, 2011

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014