BEUDAMED
    20 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 ×

    PF2

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040008331·Zirlux 16+ 0M3 89x17x16

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0120120·Screwdriver, NIDO Assembled Screws, Sleeved

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0120020·Driver Shaft, Final Tighten

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120120·Screwdriver, Polyaxial, Standard

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120020·T-Handle, T25, Screw Height Adjuster

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120220·Assembly, Screwdriver, Extended Tab

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 23, 2021

    INSET GUARD

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·October 23, 2025

    STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SAMSUNG 10DR IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007

    CLINITEK ATLAS

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code KQO·March 12, 2013

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·February 28, 2011

    BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·October 27, 2021

    BD PLASTIPAK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·October 29, 2021

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·September 16, 2021

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·October 14, 1997

    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

    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