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

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    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TO BE ASSIGNED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033540039·

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613252236962·LOCKING PLATE,SAGIT. SPLIT,STR,7MM BAR

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506082634·5MM, 45CM KNOT PUSHER, CLOSED CONE AND HANDLE W...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180149922·5 MM 45 CM, CLOSED LOOP KNOT PUSHER, STYLE 9

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506074332·ELMED KNOT PUSHER, CLOSED, STAINLESS STEEL 5mm ...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180160187·STRAIGHT OPEN ENDED KNOT PUSHER - LONG # 6

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180173293·ELMED KNOT PUSHER, STAINLESS STEEL 5MM DIA., 45...

    VERDICT -II BAR/BZO

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    FORTROSS BONE VOID FILLER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 20, 2019

    PLEURX DRAINAGE KIT 1000ML - 50-7510

    FDA Adverse Event
    Malfunction ·Product code DWM·July 23, 2021

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 8, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

    PROMOTE PLUS CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·September 18, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015