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

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    MYCOPLASMA IGG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091033064·Baltic Denture System BDLoad Mn6 PLSEbim6DFm D2...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319718094·Meyhoefer Chalazion Curette 5" (12.5cm), size 3...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0330040·Vise Grip, Small, 5.5mm

    TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323

    FDA 510(k)
    FDA Class 2 ·Immunology

    HEMOCLEAN

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GRAFTYS BCP (510K NUMBER: K073064)

    FDA Adverse Event
    Injury ·GRAFTYS·Product code MQV·July 11, 2013

    ABRAMS MULTIDENSITY POLYURETHAN FOAM WOUND DRESSING SYSTEM

    FDA Adverse Event
    Other ·DR LEN'S MEDICAL PRODUCTS·Product code FRO·October 11, 2005

    2.4MM TI HDLSS COMPRESSION SCR 24MM/SHORT THREAD-STERILE

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·June 29, 2018

    INTERSTIM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code EZW·April 3, 2013

    HILL-ROM 100 LOW BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 28, 2011

    ADVANCED CONTROL PAD SYSTEM

    FDA Adverse Event
    MIZUHO ORTHOPEDIC SYSTEMS, INC.·Product code FWY·April 21, 2008

    EMBRYO RPLCMNT CATHETER

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019

    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 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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013