BEUDAMED
    20 results · 24ms · Sources: EU EUDAMED, US FDA

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    N LP(A) STANDARD SY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Waterpik Key-To Alginate Impression Material

    FDA UDI
    WATER PIK, INC.·D6860131261·Heavy Body, Fast Set

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132160·Trial, TLIF, 27L OB CRV 7Deg, 16mm

    PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BIPOLAR TRIGGER-FLEX PROBE

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

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·March 20, 2013

    ASR XL TAP SLV ADAP 12/14+5

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

    ULTRASOFT LANCING DEVICE

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code FMK·March 14, 2008

    SYNVISC ONE (SYNVISC ONE)

    FDA Adverse Event
    Injury ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·April 2, 2014

    AXIOM ARISTOS VX PLUS

    FDA Adverse Event
    Injury ·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·January 20, 2017

    VALIANT

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 30, 2013

    TALENT TAA

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 30, 2013

    PROSTHESIS INTERVERTEBRAL DISC

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code MJO·December 17, 2013

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code BWC·September 4, 2019

    UNKNOWN HIP FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 2, 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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    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