BEUDAMED
    27 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    NHancer Rx

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517578273·CoRoent Ant TLIF Ti 10x10x32mm 4°

    Allograft Tamp

    FDA UDI
    Treace Medical Concepts, Inc.·00810111224178·TMC Allograft Tamp

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694034500·1.6mm Pilot Drill 6mm Stop Robust

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180149830·CLEANING BRUSH FOR 5 & 6 MM TROCAR SLEEVE, EACH

    VIDAS® LYME IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LSR·August 21, 2019

    Power Cord, Autolith Touch, North America

    FDA UDI
    NORTHGATE TECHNOLOGIES INC.·00817183020462·Power cord for use with Autolith Touch Lithotri...

    VIDAS® LYME IGG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code LSR·October 10, 2019

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LIFESTYLE OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 11, 2021

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON LABORATORIES, INC./HUNTINGTON·Product code HQL·June 16, 2006

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·CARROLL HEALTHCARE·Product code FNL·July 1, 2013

    LINER FOR METAL BACK GLENOID STANDARD

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·November 23, 2020

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 25, 2013

    EXPRESSEW III NEEDLE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code LXH·November 4, 2022

    Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2015

    Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 17, 2014