BEUDAMED
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    VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450141908·

    TLS 5.0

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B0301000502220·Rotating Distractor, QC, IBFD, 9mm

    BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR (TSA II)-I PLATE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSH·May 11, 2021

    OHMEDA MEDICAL GIRAFFE INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UM-L25

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

    NEOFLON 26GA 0.6MM OD 19MM L

    FDA Adverse Event
    Injury ·Product code FOZ·October 1, 2021

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·October 8, 2012

    EndoVive 3s Low Profile Balloon Kits Part Number: M00549320 (XMD P/N 70-0050-222) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Enforcement
    Class II ·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·April 5, 2013

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011

    ENDEAVOR RX

    FDA Adverse Event
    Death ·MEDTRONIC CARDIO VASCULAR GALWAY·Product code NIQ·May 22, 2008

    PROXIMATE*HCS HEMORR CIR STAPL

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 21, 2019

    PROXIMATE*PPH PROCEDURE SET

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 21, 2019

    CustMbite, Model Number CBT-SRS-UL

    FDA Enforcement
    Class II ·Ongoing·Dental Choice Holding Llc·August 10, 2022

    Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code PPD·December 4, 2025

    Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·January 28, 2026

    EndoVive 3s Low Profile Balloon Kits Part Number: M00549320 (XMD P/N 70-0050-222) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

    FDA Recall
    Terminated ·Xeridiem Mediem Medical Devices Inc·Product code PIF·December 23, 2015

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016