BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    AiMIFY (1.x)

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMNI Knee

    FDA UDI
    Omni Life Science, Inc.·00841690101925·All Poly 3 Peg Patella 29 mm x 10 mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690199311·Patella Trial 29mm x 10mm

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 7, 2021

    STOPLOSS JONES TUBE

    FDA 510(k)
    FDA Unclassified ·Unknown

    DIASORIN LIAISON CMV IGM/IGG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OT ULTRAMINI METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·July 10, 2019

    INTERLINK I.V. CONN LOOP/MALE LUER SLIP ADAPTER

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·November 24, 2008

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011

    ENOSCOPIC GASTRO RELEASE SYSTEM (EGR138)

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code NBH·July 18, 2013

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·October 20, 2023

    MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.

    FDA Enforcement
    Class II ·Ongoing·Stryker Corporation·February 25, 2026

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013