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

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    MISSION CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091033063·Baltic Denture System BDLoad ↓ Sw6 PLSEum6DFs D...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319718087·Meyhoefer Chalazion Curette 5" (12.5cm), size 2...

    GRIP LOCK ANCHOR, MODEL 411374

    FDA 510(k)
    FDA Class 2 ·Neurology

    GIMBEL PUNCTURE RESISTANT LATEX SURGICAL GLOVE WITH PUNCTURE RESISTANCE FINGERTIP PROTECTION

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 7, 2025

    TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSX·February 3, 2017

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MRU·April 3, 2013

    DISP HNDSW PENCIL W/HOLSTER

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·February 28, 2011

    CRCS

    FDA Adverse Event
    Other ·COLTENE/WHALEDENT INC.·Product code EMA·April 21, 2008

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024