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

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    SMARTXIDE PRO

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257127421·30-40 MV FOR MEN SEL CALF STD BLK VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257142110·30-40 MFW VITALITY CALF CT EBONY VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257126004·30-40 MV FOR MEN CLSC CALF STD BLK VII

    AMS APOGEE VAULT SUSPENSION SYSTEM

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    TENURE4G

    FDA 510(k)
    FDA Class 2 ·Dental

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    DEXTRUS 4137

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·November 10, 2014

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011

    1.4MM X 12.8MM FLUTED ROUTER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014