BEUDAMED
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    RHODIA DENTAL PUTTY IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496013129·RELAX UNISEX 70, SIZE M, ECRU, GRADUATED COMPRE...

    SIGN IM NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONTACT DETACH

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 5, 2025

    STYLE 468 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·July 21, 2020

    12/14 ARTICUL 40MM M SPEC+5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·March 20, 2013

    ASR ACETABULAR IMPLANT 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·March 11, 2008

    Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.

    FDA Enforcement
    Class II ·Terminated·Advanced Bionics, LLC·April 10, 2019

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; 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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    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