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

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    OSSEOTITE 2 DENTAL IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089445455·

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321112160·

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0112160·Rasp, 16 and 18 mm

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089451036·

    ZAVATION ROD CONNECTOR

    FDA UDI
    Zavation LLC·00197157016203·ROD CONNECTOR, PARALLEL CLOSED 16mm OFFSET, Ø 4...

    AUDIT MICROCV PROTEIN LINEARITY SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PVC FREE INTRAVASCULAR ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·August 30, 2024

    INSULIN PUMP

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 2, 2016

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 2, 2016

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 2, 2019

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·November 16, 2016

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 8, 2016

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·December 23, 2015

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON)·Product code OTP·May 8, 2013

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·September 23, 2014

    CATH TEMPO 5

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code DQO·June 2, 2011