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

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    NEUROPLUS, MODEL A10040, A10041, A10042, A10043

    FDA 510(k)
    FDA Class 2 ·Neurology

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964151545·Endo Carry-on Procedure Kit contains Intercept ...

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890106380·Zirlux Titanium Screw compatible with: Nobel Bi...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450130629·

    DENTSPLY DETREY GmbH

    FDA registration
    DENTSPLY DETREY GmbH·10 products·🇩🇪 Germany

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0106080·Trial, 26 x 8mm, 8 Degree, Tapered, Straight

    INSET II

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 15, 2025

    O-RING PROSTHETIC ATTACHMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    RESPONDER 3000

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 10, 2025

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 14, 2013

    TRIATHLON-SYMMETRIC PATELLA S27MM X 8MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·February 24, 2011

    RIATA ST OPTIM PASSIVE FIXATION LEAD

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

    PROXIMAL HUMERUS, LEFT, 7X160MM

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·August 4, 2021

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023