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

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    MTP DISPOSABLE TROCAR VALVES

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

    NA

    FDA UDI
    Conmed Corporation·10653405050889·American Dilator Cleaning Adaptors

    Preference 2

    FDA UDI
    SINTX Technologies, Inc.·M555159000337·6.5mm Reduction Caddy Block

    FlowLogic Agile

    FDA UDI
    SONENDO, INC.·00810209421069·FlowLogic Agile Shaping File 20 Variable, 25mm

    MONOFILAMENT BIOSYN SUTURE

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

    ENHANCED COMPENSATING FILTER

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code KXT·March 12, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·February 18, 2011

    ICY HOT HEAT THERAPY

    FDA Adverse Event
    Injury ·CHATTEM, INC.·Product code IMD·February 13, 2008

    4F M-I STIFFEN 40CM NT-SS (610366)

    FDA Adverse Event
    Malfunction ·GALT MEDICAL CORP.·Product code DQX·January 10, 2012

    WALLACH ULTRA FREEZE

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GEH·August 23, 2023

    CB040, 5MMX45CM EPIX LAPA SCISSOR, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code HET·March 1, 2022

    CB040, 5MMX45CM EPIX LAPA SCISSOR, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code HET·March 2, 2022

    BrightView product code: 882478 BrightView X product code: 882480 BrightView XCT product code: 882482 and 882454

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 3, 2014

    Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·March 5, 2014

    BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    BrightView XCT

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 22, 2017

    BrightView XCT , Model Number 882482

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 31, 2019

    BrightView XCT, Gamma Camera, Product Code 882482

    FDA Enforcement
    Class II ·Ongoing·Philips North America·January 17, 2024

    BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·September 14, 2016