BEUDAMED
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    LIAISON® Folate

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code OZO·July 2, 2019

    S9 VPAP ADAPT WITH H5I

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

    I-STAT E3+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 31, 2020

    TRI-LOCK BPS SZ 4 STD OFFSET

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code MRA·October 22, 2014

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·June 27, 2013

    WASHER 13.0MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HTN·July 1, 2011

    BD CTGCTV2 FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code LSL·April 10, 2025

    BD CTGCTV2 FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code LSL·April 10, 2025

    2008 Series Hemodialysis Machines: 2008K2 with the following product code and description: 190633 2008K2 HEMO SYSTEM, OPTIONAL MODULE; 190618 2008K2 HEMODIALYSIS SYS OLC/DP, SPANISH; 190610 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; 190630 2008K2 MACHINE, SHORT CAB, OLC/DP, HP; 190628 2008K2 OLC ONLY WITH HEPARIN PUMP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·May 6, 2015

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020