BEUDAMED
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    SUMITOMO PROTON THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M1304260·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450314661·

    LITE PELVIC FLOOR REPAIR KITS

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    OMNILUX RED

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·October 10, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·November 15, 2006

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 24, 2013

    OXF ANAT BRG LT MD SIZE 6 PMA

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code NRA·September 30, 2014

    MERIT STIFFENED DILATOR MINI ACCESS KITS

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code DRE·June 14, 2011

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·November 18, 2013

    ADULT UNHEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZO·October 2, 2013

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·October 6, 2013

    Epidural Tray Catalog 1577

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013

    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·July 24, 2013

    DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 27, 2013