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

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    DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Integrity-SI Fusion System

    FDA UDI
    Lincotek Medical LLC·B57112521012081D0·12 x 80 mm SI Implant with HA Coating

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120110·Assembly, Screwdriver, Polyaxial, Cannulated, L...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07310K0120010·Screwdriver, Tower Tab, Cannulated

    Ocata Anterior Cervical System

    FDA UDI
    Kalitec Direct LLC·B07308K0120010·Draw Rod, Universal Assembly

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120210·Assembly, Screwdriver, Extended Tab, Cannulated...

    ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 14, 2025

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 21, 2022

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·August 11, 2014

    FREESTYLE

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

    12MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/440MM/RT-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HSB·March 20, 2013

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS, LLC·Product code MCM·March 1, 2011

    HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH FOR CEMENTED USE ONLY

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code JDC·April 27, 2022

    ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT FOR CEMENTED USE ONLY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·April 27, 2022

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024