BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FALLS CREEK

    FDA UDI
    FGX INTERNATIONAL INC.·00193033500279·

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134110·Trial, TLIF, 27L OB STR 7Deg, 11mm

    FALLS CREEK

    FDA UDI
    FGX INTERNATIONAL INC.·00708820706187·

    MACHNET CAROTIDS COIL ARRAY ASSEMBLY

    FDA 510(k)
    FDA Class 2 ·Radiology

    HELIOSEAL CLEAR CHROMA

    FDA 510(k)
    FDA Class 2 ·Dental

    IMPL TWIST MTX 3.75 MM 10 MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 17, 2024

    SMALL HOHMANN RETRACTOR 6MM SHORT NARROW TIP 160MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GAD·March 20, 2013

    ITREL 3

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·February 3, 2011

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·March 10, 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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    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