BEUDAMED
    20 results · 24ms · 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 ×

    Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780463436·Barraquer Needle Holder 5-1/2", Smooth Jaws, Cu...

    RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BLAKE DRAIN

    FDA Adverse Event
    Malfunction ·ETHICON·Product code KOG·July 28, 2011

    DETACHAPORT OBTURATOR AND SEAL SET

    FDA Adverse Event
    Injury ·CONMED CORPORATION·Product code GCJ·June 21, 2013

    FEMORAL CANAL TIP

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS PUERTO RICO·Product code FQH·September 24, 2008

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 2/17 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 16, 2021

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·March 17, 2022

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·September 29, 2021

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 4, 2019

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·June 3, 2022

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·August 15, 2022

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·January 30, 2023

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·February 6, 2023

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·July 27, 2021

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·November 4, 2022

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·March 28, 2022

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·August 18, 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