BEUDAMED
    22 results · 18ms · Sources: EU EUDAMED, US FDA

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    GENTLE COLONICS IRRIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002102·artVeneer life upper posteriors, L, C2

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159018080·Dennis Anastomosis Clamp

    Personalized Patient Supplies

    FDA UDI
    Ortho Organizers, Inc.·00190707089832·Orthodontic Patient Kits - Personalized

    BOTANIQ

    FDA UDI
    Inspecs U.S.A., L.C.·00841543148374·SUNGLASS

    Kleiner KG2 system

    FDA UDI
    Baat Medical Products B.V.·08720246783377·Lid

    Baby Gorilla®/Gorilla® Plating System

    FDA UDI
    Paragon 28, Inc.·00889795034946·MTP Spin Guard™ Female Reamer, 21mm

    PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·January 31, 2023

    BIOMET MICROFIXATION FACIAL PLATING SYSTEM

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·March 20, 2017

    DEXTRUS 4137

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·March 13, 2013

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 4, 2011

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 20, 2008

    UNSPECIFIED BD OPTIMA CONNECTOR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FPA·April 29, 2021

    INJECTOR N35-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FPA·January 7, 2021

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·August 2, 2011

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013