BEUDAMED
    22 results · 29ms · Sources: EU EUDAMED, US FDA

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    POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001190·artVeneer life lower anteriors, UBM, B1

    CARESTREAM DRX-EVOLUTION

    FDA UDI
    CARESTREAM HEALTH, INC.·60889978001194·DRX-EVOLUTION/P-PCSH-P-X W/INWP

    Integra®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780167914·Integra® Module, UltraLite®, gray

    Medline

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918191782·Femoral Angiography drape_W/ windows_75inx148in...

    Health-Tec/DHP Hand Instruments

    FDA UDI
    Dental Health Products Inc·D77370011900·Health-Tec/DHP Cord Packer Standard Serrated DE

    5 Piece ClikRay (TM) "H" Holder

    FDA UDI
    CLIKTECH LLC·00856200001190·5 Piece ClikRay (TM) "H" Holder

    RIVA Posterior Fixation System

    FDA UDI
    XENIX MEDICAL LLC·00840493415246·Set Screw Caddy Base

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494461934·Dilator Single Hole D 10.0, WL 185mm

    METHAFILCON A

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODIFICATION TO CARTO EP NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INGEVITY MRI

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NVN·October 22, 2024

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 11, 2015

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 24, 2011

    OLYMPUS

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDS·February 22, 2008

    HERO GRAFT

    FDA Adverse Event
    Death ·CRYOLIFE, INC.·Product code DSY·October 15, 2015

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016