BEUDAMED
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    Happy Ring Health Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257125878·30-40 MV FOR MEN CLSC CALF STD GREY VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257127353·30-40 MV FOR MEN SEL CALF STD GREY VI

    PULPDENT VLC RESIN CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    AILERON INTERSPINOUS FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·February 12, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    3MM FLUTED BALL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GFF·July 17, 2013

    GLENOID RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 15, 2025

    MEDROXYPROGESTERONE ACETATE

    FDA Adverse Event
    Malfunction ·LABORATORIES FARMALAN S.A.·Product code FMF·September 23, 2025

    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