BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    Obturys

    FDA 510(k)
    FDA Class 2 ·Dental

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197067034·Ragnell Davis Retractor 8x4mm/...

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 24, 2022

    NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MULTI-ANALYTE CHEMISTRY CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

    Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Number 58403-000). Intended for patients for whom the monitoring of continuous cardiac output is indicated for diagnostic and prognostic evaluation by a clinician in the hospital.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 16, 2018

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON INC·Product code OTN·June 14, 2013

    FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33 PERCENT CEL

    FDA Adverse Event
    Other ·PROCTER & GAMBLE MANUFACTURING CO.·Product code KOO·July 5, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    STEALTHSTATION S7

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·September 16, 2021

    BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 2, 2013

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024