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

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    Synthetic Polyisoprene Lubricated Male Condom - 5 senses

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528127919·2.4 X 38mm Cannulated Headed Screw, T7

    TITAN MODULAR TOTAL SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRIMALOK FACET FIXATION SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·October 17, 2014

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 14, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 18, 2011

    RHYTHMIA HDX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·October 16, 2025

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024