BEUDAMED
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    CREATININE PLUS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102855·CAMLOG® Screw-Line-compatible 3.3mm X 4.5mm Tit...

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003116·Jacobson Micro Needle Holder Flat Knurled Handle

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450125892·

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 21, 2026

    L720 EXAMINATION CHAIR

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

    HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 26, 1997

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 28, 2011

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Death ·ETHICON, INC.·Product code GAW·February 27, 2008

    TMJ SYSTEM CROSS DRIVE FOSSA SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·June 1, 2018

    TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·June 1, 2018

    TMJ SYSTEM CROSS DRIVE FOSSA SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·June 1, 2018

    INSORB 30 STAPLER

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GAG·December 27, 2022

    "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·June 1, 2018

    SINGLE USE ELECTROSURGICAL KNIFE KD-645

    FDA Adverse Event
    Injury ·AOMORI OLYMPUS CO., LTD.·Product code KNS·October 12, 2023

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016