BEUDAMED
    34 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    TRIAD ORTHODONTIC GEL

    FDA 510(k)
    FDA Class 2 ·Dental

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65888824821·Urology Pack

    Archon

    FDA UDI
    Nuvasive, Inc.·00887517251336·Archon Plate, 82mm 4-Level Wide

    KEOFEED (R) EASY-FILL ENTERIC FEED BAG

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

    FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 23, 2017

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 18, 2014

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 21, 2010

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·December 20, 2012

    BRIGHTVIEW

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·Product code KPS·January 15, 2026

    BrightView XCT , Model Number 882482

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·June 10, 2019

    BrightView XCT, Gamma Camera, Product Code 882482

    FDA Recall
    Open, Classified ·Philips North America·Product code KPS·November 30, 2023

    BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 9, 2014

    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 Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·May 25, 2016

    BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 4, 2015

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

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·November 4, 2014

    BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161

    FDA Recall
    Open, Classified ·Philips North America·Product code KPS·December 15, 2023

    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