BEUDAMED
    29 results · 23ms · Sources: EU EUDAMED, US FDA

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    Facet-Link Stabilization Platform

    FDA 510(k)
    FDA Unclassified ·Unknown

    Oticon

    FDA UDI
    Oticon A/S·05707131286482·H16V2 TI, MINIRITE 312 WL DBL

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197512985·VATS NODE Klemme left c...

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011150223000·O-Tray impression tray for Mandibular, Size L3

    VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER

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

    WAVEGUARD (TM) EEG CAP

    FDA 510(k)
    FDA Class 2 ·Neurology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 20, 2022

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 17, 2023

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·December 17, 2019

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·December 21, 2016

    PASSIVE PLANAR BLUNT PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 22, 2015

    PASSIVE PLANAR BLUNT PROBE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 22, 2015

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·November 13, 2019

    Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·June 24, 2015

    RADIFOCUS OPTITORQUE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

    PFC SIGMARP CVTBIN S2.5 10.0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS·Product code NJL·June 6, 2013

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    FDA Adverse Event
    Injury ·BIOENTRICS CORP·Product code LTI·September 3, 2008

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·June 10, 2011

    EXPRESSSEW III AC GUN

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

    AIRVO2 HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 15, 2015