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

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    Free Testosterone AccuBind ELISA Test System

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INTERSURGICAL ECOLITE™, ADULT, HIGH CONCENTRATION OXYGEN MASK AND TUBE, 2.1M

    FDA UDI
    Intersurgical Incorporated·05030267157891·INTERSURGICAL ECOLITE™, ADULT, HIGH CONCENTRATI...

    Portex

    FDA UDI
    ICU MEDICAL, INC.·00351688017379·

    VIDAS® TSH ASSAY

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, S.A.·Product code KLI·July 5, 2018

    Spex

    FDA UDI
    SPEX LIMITED·09420051707351·Spex Webbing Heel loops - Complete Small

    IN-OVATION® R

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K189017081·IN-OVATION® R CCO® 018 U 5-5/L5-5 CS-BC HK

    IN-OVATION® R

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K189017181·IN-OVATION® R CCO® 022 U5-5/L5-5 CS-BC HK

    IN-OVATION® R

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K189017171·IN-OVATION® R CCO® 022 U5-5/L5-5 CS HK

    IN-OVATION® R

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K189017071·IN-OVATION® R CCO® 018 U 5-5/L5-5 CS HK

    TEMPLATE AND COUNTER-FIT

    FDA 510(k)
    FDA Class 2 ·Dental

    ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PGA

    FDA Adverse Event
    Malfunction ·CP MEDICAL·Product code GAM·December 11, 2019

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code FSA·June 20, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DRY·July 1, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS .·Product code LFR·September 29, 2008

    640G INSULIN PUMP MMT-1712H

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 3, 2022

    CUSA EXCEL 36KHZ STRAIGHT HANDPIECE

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·October 18, 2019

    3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.

    FDA Enforcement
    Class II ·Ongoing·Arthrex, Inc.·November 21, 2018

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022

    ROSA Brain 3.0 Application-Brain

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·February 19, 2020