BEUDAMED
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    POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111

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

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810003861·Endoflex K-Files 25 mm

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040062340·Endoflex K-Files 25 mm

    TEWA

    FDA UDI
    asia-med GmbH·04251282508418·TeWa CB-Type 3075: coated acupuncture needles ...

    TEWA

    FDA UDI
    asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG·04251282501099·TeWa CB-Type 3075: coated acupuncture needles ...

    intellijoint HIP(R)

    FDA UDI
    Intellijoint Surgical Inc·00628184003862·Flat Tip, Femoral Disc Inserter

    NA

    FDA UDI
    David Scott Company·15060797554164·Infinity Clamp

    IV TUBING, 100 ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code FPA·January 13, 1994

    DATEX-OHMEDA INOVENT DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WILSON-COOK REUSABLE HOT BIOPSY FORCEPS

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

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 22, 2023

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·March 12, 2013

    OLYMPUS LIGHT SOURCE

    FDA Adverse Event
    Other ·OLYMPUS MEDICAL SYSTEM CORPORATION·Product code GCT·February 9, 2011

    SIG MOD TIB TRAY CEM COCR 2.5

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 19, 2008

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 30, 2021

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 30, 2021

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 26, 2022

    EVIS EXERA III BRONCHOVIDEOSCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code EOQ·August 23, 2024

    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 model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only). BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 12, 2017