BEUDAMED
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    STRYKER REMOTE SURGICAL PLANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00140271·

    artegral life HD

    FDA UDI
    Merz Dental GmbH·D7092004027·artegral life HighDefinition posterior lower -M...

    Alleset

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918142159·Needle Counter_40-Count_Foam Block_Adhesive_N/S...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523160556·3mm Kerrison Rongeur, Short Grip

    INSUFFLATION NEEDLE, MODEL R65-933

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

    DR180+OXY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 36XØ24.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSD·February 7, 2022

    COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 29, 2025

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QFG·May 7, 2026

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 7, 2011

    I-PORT

    FDA Adverse Event
    Injury ·PATTON MEDICAL DEVICES·Product code FOZ·February 6, 2008

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO·Product code DTB·February 25, 2008

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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