BEUDAMED
    24 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ACCU-SPACE ABSORBABLE SEEDING SPACERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964151453·Endo Carry-on Procedure Kit contains Intercept ...

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890106210·Zirlux Titanium Abutment 4.5 mmH compatible wit...

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100210·SNII Awl Tap, 5.50mm

    InSePtion MIS Fixation System

    FDA UDI
    Kalitec Direct LLC·B07314K0100210·Caddie Lid, Implant

    Matira

    FDA UDI
    Kalitec Direct LLC·B07307K0100210·Assembly, Caddie, Plates and Screws, Hinged

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100210·Caddie Lid, Rods, 5.5mm

    DARDIK CAROTID SHUNT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100

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

    BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 6, 2022

    TORNIER STAYFUSE GREAT TOE INTERPHALANGEAL IM

    FDA Adverse Event
    Malfunction ·TORNIER INC.·Product code NDF·October 22, 2009

    NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·March 19, 2013

    HEAD FOR ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code JDI·February 24, 2011

    RIATA ST OPTIM PASSIVE-FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 31, 2019

    Q-SYTE CLOSED LUER ACCESS DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·November 13, 2020

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·July 8, 2022

    BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·March 7, 2018

    Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

    FDA Enforcement
    Class II ·Ongoing·Lacrimedics Inc·March 9, 2022

    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