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

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    UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    METZENBAUM SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896054738·METZENBAUM SCISSORS CURVED BLADES POWER CUT GOLD

    MTP Trial

    FDA UDI
    Treace Medical Concepts, Inc.·00810111224123·TMC MTP Trial, 5mm

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694006514·.9mm Pilot Drill, 3mm Stop, J-Latch

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776165581·OLLIER RETRACTOR BLUNT PRONGS . LONG

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113318·PHACO KNIFE 1.8MM ANGLED (BX/5)

    SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES

    FDA 510(k)
    FDA Unclassified ·Unknown

    BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MICROTEK

    FDA Adverse Event
    Malfunction ·MICROTEK MEDICAL INC.·Product code KPE·November 5, 2020

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 25, 2021

    ILET BIONIC PANCREAS

    FDA Adverse Event
    Malfunction ·BETA BIONICS INC.·Product code QFG·November 19, 2025

    SOFTCLIX ® LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·October 24, 2014

    COLLEAGUE PRE P1.7

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

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.

    FDA Enforcement
    Class I ·Terminated·B Braun Medical Inc·May 11, 2016

    FALLOPIAN TUBE OCCLUSION INSERT

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 17, 2025

    FALLOPIAN TUBE OCCLUSION INSERT

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 17, 2025

    MBT CEM TIBIAL TRAY SZ3

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code NJL·May 8, 2017

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MRU·May 17, 2016

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MRU·May 17, 2016